A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications

May 4, 2018 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Severe Persistent Asthma Uncontrolled on High Dose Inhaled Corticosteroid Therapy

The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

889

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia
        • Teva Investigational Site 85570
      • Parkville, Australia
        • Teva Investigational Site 85571
  • Bulgaria
      • Burgas, Bulgaria
        • Teva Investigational Site 59507
      • Lovech, Bulgaria
        • Teva Investigational Site 59503
      • Pleven, Bulgaria
        • Teva Investigational Site 59506
      • Ruse, Bulgaria
        • Teva Investigational Site 59504
      • Sofia, Bulgaria
        • Teva Investigational Site 59501
      • Sofia, Bulgaria
        • Teva Investigational Site 59502
      • Sofia, Bulgaria
        • Teva Investigational Site 59505
      • Sofia, Bulgaria
        • Teva Investigational Site 59508
      • Varna, Bulgaria
        • Teva Investigational Site 59509
  • Canada
      • Newmarket, Canada
        • Teva Investigational Site 11591
    • Ontario
      • Burlington, Ontario, Canada
        • Teva Investigational Site 11594
      • Etobicoke, Ontario, Canada
        • Teva Investigational Site 11595
      • Sarnia, Ontario, Canada
        • Teva Investigational Site 11592
      • Toronto, Ontario, Canada
        • Teva Investigational Site 11590
  • Croatia
      • Zagreb, Croatia
        • Teva Investigational Site 85501
      • Zagreb, Croatia
        • Teva Investigational Site 85502
      • Zagreb, Croatia
        • Teva Investigational Site 85503
      • Zagreb, Croatia
        • Teva Investigational Site 85504
  • Germany
      • Berlin, Germany
        • Teva Investigational Site 70561
      • Bonn, Germany
        • Teva Investigational Site 70564
      • Cottbus, Germany
        • Teva Investigational Site 70557
      • Delitzsch, Germany
        • Teva Investigational Site 70553
      • Frankfurt, Germany
        • Teva Investigational Site 70558
      • Hamburg, Germany
        • Teva Investigational Site 70562
      • Hanover, Germany
        • Teva Investigational Site 70560
      • Leipzig, Germany
        • Teva Investigational Site 70555
      • Magdeburg, Germany
        • Teva Investigational Site 70556
      • Munchen, Germany
        • Teva Investigational Site 70550
      • Munchen, Germany
        • Teva Investigational Site 70554
      • Munster, Germany
        • Teva Investigational Site 70552
      • Nurnberg, Germany
        • Teva Investigational Site 70563
      • Rudersdorf, Germany
        • Teva Investigational Site 70551
      • Wiesbaden, Germany
        • Teva Investigational Site 70559
  • Greece
      • Athens, Greece
        • Teva Investigational Site 85533
      • Athens, Greece
        • Teva Investigational Site 85534
      • Heraklion, Greece
        • Teva Investigational Site 85531
      • Larissa, Greece
        • Teva Investigational Site 85532
      • Thessaloniki, Greece
        • Teva Investigational Site 85530
  • Hungary
      • Balassagyarmat, Hungary
        • Teva Investigational Site 36507
      • Budapest, Hungary
        • Teva Investigational Site 36504
      • Budapest, Hungary
        • Teva Investigational Site 36505
      • Csoma, Hungary
        • Teva Investigational Site 36514
      • Erd, Hungary
        • Teva Investigational Site 36516
      • Kaba, Hungary
        • Teva Investigational Site 36513
      • Kaposvar, Hungary
        • Teva Investigational Site 36515
      • Miskolc, Hungary
        • Teva Investigational Site 36503
      • Nyiregyhaza, Hungary
        • Teva Investigational Site 36502
      • Siofok, Hungary
        • Teva Investigational Site 36510
      • Szarvas, Hungary
        • Teva Investigational Site 36517
      • Szazhalombatta, Hungary
        • Teva Investigational Site 36508
      • Szeged, Hungary
        • Teva Investigational Site 36506
      • Szeged, Hungary
        • Teva Investigational Site 36509
      • Szombathely, Hungary
        • Teva Investigational Site 36501
      • Veszprem, Hungary
        • Teva Investigational Site 36512
  • Ireland
      • Dublin, Ireland
        • Teva Investigational Site 59550
      • Dublin, Ireland
        • Teva Investigational Site 59551
  • Israel
      • Ashkelon, Israel
        • Teva Investigational Site 72511
      • Haifa, Israel
        • Teva Investigational Site 72501
      • Haifa, Israel
        • Teva Investigational Site 72512
      • Jerusalem, Israel
        • Teva Investigational Site 72502
      • Jerusalem, Israel
        • Teva Investigational Site 72504
      • Kfar Saba, Israel
        • Teva Investigational Site 72509
      • Petach Tikva, Israel
        • Teva Investigational Site 72506
      • Ramat-Gan, Israel
        • Teva Investigational Site 72507
      • Rehovot, Israel
        • Teva Investigational Site 72503
      • Tel Aviv, Israel
        • Teva Investigational Site 72510
      • Tel-Aviv, Israel
        • Teva Investigational Site 72508
      • Zerifin, Israel
        • Teva Investigational Site 72505
  • New Zealand
      • Auckland, New Zealand
        • Teva Investigational Site 81571
      • Christchurch, New Zealand
        • Teva Investigational Site 81572
      • Tauranga, New Zealand
        • Teva Investigational Site 81573
      • Wellington, New Zealand
        • Teva Investigational Site 81570
  • Poland
      • Bialystok, Poland
        • Teva Investigational Site 48507
      • Bydgoszcz, Poland
        • Teva Investigational Site 48505
      • Grodzisk Mazowiecki, Poland
        • Teva Investigational Site 48506
      • Lodz, Poland
        • Teva Investigational Site 48501
      • Lodz, Poland
        • Teva Investigational Site 48509
      • Lublin, Poland
        • Teva Investigational Site 48513
      • Poznan, Poland
        • Teva Investigational Site 48508
      • Poznan, Poland
        • Teva Investigational Site 48512
      • Strzelce Opolskie, Poland
        • Teva Investigational Site 48502
      • Tarnow, Poland
        • Teva Investigational Site 48503
      • Wroclaw, Poland
        • Teva Investigational Site 48504
  • Romania
      • Brasov, Romania
        • Teva Investigational Site 81534
      • Brasov, Romania
        • Teva Investigational Site 81539
      • Bucharest, Romania
        • Teva Investigational Site 81533
      • Bucharest, Romania
        • Teva Investigational Site 81535
      • Bucharest, Romania
        • Teva Investigational Site 81537
      • Cluj-Napoca, Romania
        • Teva Investigational Site 81531
      • Cluj-Napoca, Romania
        • Teva Investigational Site 81536
      • Targu Mures, Romania
        • Teva Investigational Site 81530
      • Timisoara, Romania
        • Teva Investigational Site 81532
      • Timisoara, Romania
        • Teva Investigational Site 81538
  • Russian Federation
      • Barnaul, Russian Federation
        • Teva Investigational Site 70505
      • Kazan, Russian Federation
        • Teva Investigational Site 70502
      • Moscow, Russian Federation
        • Teva Investigational Site 70511
      • Moscow, Russian Federation
        • Teva Investigational Site 70512
      • Ryazan, Russian Federation
        • Teva Investigational Site 70508
      • Samara, Russian Federation
        • Teva Investigational Site 70509
      • Smolensk, Russian Federation
        • Teva Investigational Site 70507
      • St. Petersburg, Russian Federation
        • Teva Investigational Site 70501
      • St. Petersburg, Russian Federation
        • Teva Investigational Site 70504
      • St. Petersburg, Russian Federation
        • Teva Investigational Site 70510
      • Tomsk, Russian Federation
        • Teva Investigational Site 70506
      • Yaroslavl, Russian Federation
        • Teva Investigational Site 70503
  • Serbia
      • Belgrade, Serbia
        • Teva Investigational Site 81501
  • South Africa
      • Bloemfontein, South Africa
        • Teva Investigational Site 36551
      • Cape Town, South Africa
        • Teva Investigational Site 36552
      • Cape Town, South Africa
        • Teva Investigational Site 36555
      • Port Elizabeth, South Africa
        • Teva Investigational Site 36550
      • Thabazimbi, South Africa
        • Teva Investigational Site 36553
      • Witbank, South Africa
        • Teva Investigational Site 36554
  • Spain
      • Aranjuez, Spain
        • Teva Investigational Site 34507
      • Badalona, Spain
        • Teva Investigational Site 34501
      • Barcelona, Spain
        • Teva Investigational Site 34502
      • Barcelona, Spain
        • Teva Investigational Site 34510
      • Bilbao, Spain
        • Teva Investigational Site 34509
      • Lleida, Spain
        • Teva Investigational Site 34506
      • Madrid, Spain
        • Teva Investigational Site 34505
      • Salt, Spain
        • Teva Investigational Site 34503
      • Santiago de Compostela, Spain
        • Teva Investigational Site 34504
      • Valencia, Spain
        • Teva Investigational Site 34508
      • Vitoria, Spain
        • Teva Investigational Site 34511
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Teva Investigational Site 80501
      • Dnipropetrovsk, Ukraine
        • Teva Investigational Site 80513
      • Donetsk, Ukraine
        • Teva Investigational Site 80511
      • Kharkiv, Ukraine
        • Teva Investigational Site 80502
      • Kharkiv, Ukraine
        • Teva Investigational Site 80503
      • Kyiv, Ukraine
        • Teva Investigational Site 80504
      • Kyiv, Ukraine
        • Teva Investigational Site 80505
      • Kyiv, Ukraine
        • Teva Investigational Site 80506
      • Kyiv, Ukraine
        • Teva Investigational Site 80507
      • Kyiv, Ukraine
        • Teva Investigational Site 80508
      • Kyiv, Ukraine
        • Teva Investigational Site 80509
      • Kyiv, Ukraine
        • Teva Investigational Site 80517
      • Kyiv, Ukraine
        • Teva Investigational Site 80519
      • Kyiv, Ukraine
        • Teva Investigational Site 80520
      • Kyiv, Ukraine
        • Teva Investigational Site 80521
      • Odesa, Ukraine
        • Teva Investigational Site 80514
      • Simferopol, Ukraine
        • Teva Investigational Site 80516
      • Vinnytsya, Ukraine
        • Teva Investigational Site 80512
      • Yalta, Ukraine
        • Teva Investigational Site 80515
      • Zaporizhia, Ukraine
        • Teva Investigational Site 80522
      • Zaporizhzhia, Ukraine
        • Teva Investigational Site 80510
      • Zaporizhzhya, Ukraine
        • Teva Investigational Site 80518
  • United Kingdom
      • Cottingham, United Kingdom
        • Teva Investigational Site 34582
      • London, United Kingdom
        • Teva Investigational Site 34584
      • Penzance, United Kingdom
        • Teva Investigational Site 34585
      • Torpoint, United Kingdom
        • Teva Investigational Site 34580
      • Watford, United Kingdom
        • Teva Investigational Site 34581
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Teva Investigational Site 10504
      • Homewood, Alabama, United States
        • Teva Investigational Site 10565
    • Arizona
      • Goodyear, Arizona, United States
        • Teva Investigational Site 11527
      • Tucson, Arizona, United States
        • Teva Investigational Site 10516
    • California
      • Bakersfield, California, United States
        • Teva Investigational Site 10573
      • Costa Mesa, California, United States
        • Teva Investigational Site 11518
      • Fountain Valley, California, United States
        • Teva Investigational Site 10590
      • Granada Hills, California, United States
        • Teva Investigational Site 10551
      • Huntington Beach, California, United States
        • Teva Investigational Site 11520
      • Huntington Beach, California, United States
        • Teva Investigational Site 11545
      • Long Beach, California, United States
        • Teva Investigational Site 10547
      • Los Angeles, California, United States
        • Teva Investigational Site 11549
      • Mission Viejo, California, United States
        • Teva Investigational Site 10503
      • Newport Beach, California, United States
        • Teva Investigational Site 10536
      • Orange, California, United States
        • Teva Investigational Site 10540
      • Orange, California, United States
        • Teva Investigational Site 11551
      • Palmdale, California, United States
        • Teva Investigational Site 10578
      • Redwood City, California, United States
        • Teva Investigational Site 10585
      • Rolling Hills Estates, California, United States
        • Teva Investigational Site 11538
      • Roseville, California, United States
        • Teva Investigational Site 11522
      • San Diego, California, United States
        • Teva Investigational Site 10582
      • San Diego, California, United States
        • Teva Investigational Site 11554
      • San Jose, California, United States
        • Teva Investigational Site 10563
      • Santa Monica, California, United States
        • Teva Investigational Site 11556
      • Stockton, California, United States
        • Teva Investigational Site 10506
      • Walnut Creek, California, United States
        • Teva Investigational Site 10529
    • Colorado
      • Centennial, Colorado, United States
        • Teva Investigational Site 10545
      • Colorado Springs, Colorado, United States
        • Teva Investigational Site 10572
      • Denver, Colorado, United States
        • Teva Investigational Site 10533
      • Denver, Colorado, United States
        • Teva Investigational Site 11531
      • Denver, Colorado, United States
        • Teva Investigational Site 11542
      • Wheat Ridge, Colorado, United States
        • Teva Investigational Site 11569
    • Connecticut
      • Waterbury, Connecticut, United States
        • Teva Investigational Site 10528
    • Florida
      • Boynton Beach, Florida, United States
        • Teva Investigational Site 10556
      • Brandon, Florida, United States
        • Teva Investigational Site 11513
      • Clearwater, Florida, United States
        • Teva Investigational Site 11507
      • Fort Myers, Florida, United States
        • Teva Investigational Site 11546
      • Hialeah, Florida, United States
        • Teva Investigational Site 11526
      • Kissimmee, Florida, United States
        • Teva Investigational Site 11525
      • Miami, Florida, United States
        • Teva Investigational Site 10537
      • Miami, Florida, United States
        • Teva Investigational Site 10553
      • Miami, Florida, United States
        • Teva Investigational Site 11508
      • Miami, Florida, United States
        • Teva Investigational Site 11514
      • Miami, Florida, United States
        • Teva Investigational Site 11516
      • Miami, Florida, United States
        • Teva Investigational Site 11530
      • Miami, Florida, United States
        • Teva Investigational Site 11570
      • Ocala, Florida, United States
        • Teva Investigational Site 10571
      • Sarasota, Florida, United States
        • Teva Investigational Site 11537
      • South Miami, Florida, United States
        • Teva Investigational Site 10593
      • Tallahassee, Florida, United States
        • Teva Investigational Site 11555
      • Tamarac, Florida, United States
        • Teva Investigational Site 10554
      • Tampa, Florida, United States
        • Teva Investigational Site 10539
      • Valrico, Florida, United States
        • Teva Investigational Site 10525
    • Georgia
      • Albany, Georgia, United States
        • Teva Investigational Site 11504
      • Columbus, Georgia, United States
        • Teva Investigational Site 10511
      • Columbus, Georgia, United States
        • Teva Investigational Site 11510
      • Columbus, Georgia, United States
        • Teva Investigational Site 11572
      • Lawrenceville, Georgia, United States
        • Teva Investigational Site 10568
      • Lilburn, Georgia, United States
        • Teva Investigational Site 10586
      • Savannah, Georgia, United States
        • Teva Investigational Site 11539
      • Stockbridge, Georgia, United States
        • Teva Investigational Site 10543
    • Indiana
      • Indianapolis, Indiana, United States
        • Teva Investigational Site 11558
      • South Bend, Indiana, United States
        • Teva Investigational Site 10527
    • Iowa
      • Iowa City, Iowa, United States
        • Teva Investigational Site 10584
    • Kansas
      • Overland Park, Kansas, United States
        • Teva Investigational Site 11501
    • Kentucky
      • Lexington, Kentucky, United States
        • Teva Investigational Site 10591
      • Louisville, Kentucky, United States
        • Teva Investigational Site 11567
    • Louisiana
      • Metairie, Louisiana, United States
        • Teva Investigational Site 10513
    • Maine
      • Bangor, Maine, United States
        • Teva Investigational Site 10564
    • Maryland
      • Baltimore, Maryland, United States
        • Teva Investigational Site 11548
      • Largo, Maryland, United States
        • Teva Investigational Site 10510
      • Wheaton, Maryland, United States
        • Teva Investigational Site 10577
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Teva Investigational Site 10538
      • North Dartmouth, Massachusetts, United States
        • Teva Investigational Site 10546
    • Michigan
      • Troy, Michigan, United States
        • Teva Investigational Site 11502
    • Minnesota
      • Plymouth, Minnesota, United States
        • Teva Investigational Site 10531
    • Missouri
      • Columbia, Missouri, United States
        • Teva Investigational Site 11562
      • Columbia, Missouri, United States
        • Teva Investigational Site 11563
      • Saint Louis, Missouri, United States
        • Teva Investigational Site 10552
      • Saint Louis, Missouri, United States
        • Teva Investigational Site 10575
      • Saint Louis, Missouri, United States
        • Teva Investigational Site 10589
      • Saint Louis, Missouri, United States
        • Teva Investigational Site 11532
    • Nebraska
      • Bellevue, Nebraska, United States
        • Teva Investigational Site 10518
      • Omaha, Nebraska, United States
        • Teva Investigational Site 10550
      • Omaha, Nebraska, United States
        • Teva Investigational Site 11529
    • Nevada
      • Las Vegas, Nevada, United States
        • Teva Investigational Site 11571
    • New Jersey
      • Cherry Hill, New Jersey, United States
        • Teva Investigational Site 10559
      • Edison, New Jersey, United States
        • Teva Investigational Site 11566
      • Hillsborough, New Jersey, United States
        • Teva Investigational Site 10501
      • Ocean City, New Jersey, United States
        • Teva Investigational Site 11550
      • West Orange, New Jersey, United States
        • Teva Investigational Site 10588
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Teva Investigational Site 11503
    • New York
      • Bronx, New York, United States
        • Teva Investigational Site 10580
      • Brooklyn, New York, United States
        • Teva Investigational Site 10587
      • New York, New York, United States
        • Teva Investigational Site 10520
      • Newburgh, New York, United States
        • Teva Investigational Site 10532
      • North Syracuse, New York, United States
        • Teva Investigational Site 10567
      • Rochester, New York, United States
        • Teva Investigational Site 10512
    • Ohio
      • Canton, Ohio, United States
        • Teva Investigational Site 10522
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 10507
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 10523
      • Columbus, Ohio, United States
        • Teva Investigational Site 10544
      • Dayton, Ohio, United States
        • Teva Investigational Site 11521
      • Middleburg Heights, Ohio, United States
        • Teva Investigational Site 11505
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Teva Investigational Site 10560
      • Oklahoma City, Oklahoma, United States
        • Teva Investigational Site 10574
      • Oklahoma City, Oklahoma, United States
        • Teva Investigational Site 10579
      • Tulsa, Oklahoma, United States
        • Teva Investigational Site 11544
    • Oregon
      • Ashland, Oregon, United States
        • Teva Investigational Site 10598
      • Medford, Oregon, United States
        • Teva Investigational Site 11543
      • Portland, Oregon, United States
        • Teva Investigational Site 11557
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Teva Investigational Site 10509
      • Philadelphia, Pennsylvania, United States
        • Teva Investigational Site 10555
      • Pittsburgh, Pennsylvania, United States
        • Teva Investigational Site 10566
      • Upland, Pennsylvania, United States
        • Teva Investigational Site 10521
    • Rhode Island
      • Lincoln, Rhode Island, United States
        • Teva Investigational Site 10581
      • Providence, Rhode Island, United States
        • Teva Investigational Site 10562
    • South Carolina
      • Charleston, South Carolina, United States
        • Teva Investigational Site 10526
      • Charleston, South Carolina, United States
        • Teva Investigational Site 11547
      • Orangeburg, South Carolina, United States
        • Teva Investigational Site 10583
      • Spartanburg, South Carolina, United States
        • Teva Investigational Site 10517
      • Spartanburg, South Carolina, United States
        • Teva Investigational Site 11515
    • Texas
      • Boerne, Texas, United States
        • Teva Investigational Site 10519
      • Dallas, Texas, United States
        • Teva Investigational Site 10541
      • Dallas, Texas, United States
        • Teva Investigational Site 10542
      • El Paso, Texas, United States
        • Teva Investigational Site 10548
      • El Paso, Texas, United States
        • Teva Investigational Site 11552
      • Fort Worth, Texas, United States
        • Teva Investigational Site 11512
      • Houston, Texas, United States
        • Teva Investigational Site 11565
      • Houston, Texas, United States
        • Teva Investigational Site 11568
      • San Antonio, Texas, United States
        • Teva Investigational Site 10515
      • San Antonio, Texas, United States
        • Teva Investigational Site 10569
      • San Antonio, Texas, United States
        • Teva Investigational Site 11517
      • San Antonio, Texas, United States
        • Teva Investigational Site 11519
      • Waco, Texas, United States
        • Teva Investigational Site 11560
    • Utah
      • Layton, Utah, United States
        • Teva Investigational Site 11528
      • Provo, Utah, United States
        • Teva Investigational Site 10576
    • Vermont
      • South Burlington, Vermont, United States
        • Teva Investigational Site 10534
    • Virginia
      • Fairfax, Virginia, United States
        • Teva Investigational Site 10502
      • Manassas, Virginia, United States
        • Teva Investigational Site 10595
      • Richmond, Virginia, United States
        • Teva Investigational Site 10508
    • Washington
      • Bellingham, Washington, United States
        • Teva Investigational Site 11561
      • Seattle, Washington, United States
        • Teva Investigational Site 11541
      • Spokane, Washington, United States
        • Teva Investigational Site 10524
      • Tacoma, Washington, United States
        • Teva Investigational Site 10530
      • Tacoma, Washington, United States
        • Teva Investigational Site 11511
    • Wisconsin
      • Greenfield, Wisconsin, United States
        • Teva Investigational Site 10570
      • Greenfield, Wisconsin, United States
        • Teva Investigational Site 11559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
  2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
  3. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
  4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).

  5. Severity of Disease:

    • A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects. ATS/ERS 2005 criteria for acceptability, reproducibility, and end of test must be met for spirometry

  6. Reversibility of Disease: Demonstrated a ≥12% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% then the subject is not eligible for the study and will not be allowed to re-screen. Reversibility values of 11.50 - 11.99 will be rounded to 12. Documented historical reversibility of ≥ 12 % within 3 months of the Screening Visit will be accepted.

  7. Current Asthma Therapy: Subjects will be required to be on a short acting β2 agonist and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and have been maintained on a stable dose of inhaled corticosteroids for four weeks prior to the Screening Visit at one of the following doses:

    • Fluticasone propionate HFA MDI ≥ 880 mcg/day
    • Fluticasone propionate DPI≥ 1000 mcg/day
    • Beclomethasone dipropionate DPI ≥ 2000 mcg/day
    • Beclomethasone dipropionate HFA (QVAR)≥ 640 mcg/day
    • Beclomethasone dipropionate HFA (Clenil Modulite)≥ 2000 mcg/day
    • Budesonide DPI ≥ 1600 mcg/day
    • Budesonide MDI ≥ 1600 mcg/day
    • Flunisolide ≥ 2000 mcg/day
    • Triamcinolone acetonide ≥ 2000 mcg /day
    • Mometasone furoate DPI ≥ 880 mcg/day
    • Ciclesonide HFA MDI ≥ 640 mcg/day

    Exception 1: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS/LABA therapy and the subject provides consent, subjects on inhaled Fluticasone propionate/salmeterol DPI ≥ 1000 mcg/day, or Fluticasone propionate/salmeterol HFA ≥ 880 mcg/day, or Fluticasone propionate/Formoterol ≥ 1000 mcg/day,or Beclomethasone dipropionate/Formoterol ≥ 400 mcg/day, or Budesonide/formoterol HFA ≥ 640 mcg/day, or Budesonide/formoterol DPI ≥ 800 mcg/day, or Mometasone furoate/formoterol MDI ≥ 800 mcg/day or subjects on a qualifying ICS dose plus a long-acting β2-agonists (LABA) administered via separate inhalers, may be switched to a qualifying dose of fluticasone propionate provided the subjects will not participate in the PK portion of the study.

    Exception 2: Subjects on a qualifying dose of fluticasone propionate who wish to participate in the PK portion of the study and who provide consent may have their fluticasone propionate switched to a different qualifying ICS (non-fluticasone propionate) at a pre-screening visit. The subject will be required to return to the clinic to complete the Screening Visit following a 1-week washout period.

  8. Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of it's use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting β2 sympathomimetic bronchodilators for at least 6 hours prior to all study visits.

  9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of

    • Non-childbearing potential, defined as:

      • Before menarche, or
      • 1 year post-menopausal, or
      • Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or
      • Congenital sterility, or
      • Diagnosed as infertile and not undergoing treatment to reverse infertility or is of

    • Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:

      • Systemic contraception used for 1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®), or
      • Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide), or
      • Intrauterine device (IUD) or
      • Monogamous with a vasectomized male partner or is of
    • Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active
  10. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc).

Exclusion Criteria:

  1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
  2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.

  3. Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening Visit. A subject must not have had any hospitalization for asthma within 2 month prior to the Screening Visit.

    Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular inhaled corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular inhaled corticosteroid maintenance treatment, or the addition of other asthma medications.

  4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
  5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.

  6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:

    • Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit)
    • Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years
    • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100)
    • Stroke within 3 months prior to the Screening Visit
    • Immunologic compromise
  7. History of a positive test for HIV, hepatitis B or hepatitis C infection.
  8. Untreated oral candidiasis at the Screening Visit. Subjects with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study
  9. History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
  10. History of severe allergy to milk protein.

  11. Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening Visit

    • Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
    • Use of intranasal corticosteroids or ocular corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
  12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
  13. Immunotherapy for the treatment of allergy at a stable maintenance dose for at least 90 days prior to the Screening Visit and which will remain at a stable dose without escalation throughout the study is permitted.
  14. Use of Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. Strong and moderate CYP3A4 inhibitors are prohibited and weak CYP3A4 are allowed.
  15. History of alcohol or drug abuse within two years preceding the Screening Visit.
  16. Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
  17. Study participation by clinical investigator site employees and/or their immediate relatives.
  18. Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
  19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
  20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fp MDPI 50 mcg

Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Drug: Fp MDPI

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.

During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

Other Names:
  • fluticasone propionate
  • Fp SPIROMAX® Inhalation Powder
Experimental: Fp MDPI 100 mcg

Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Drug: Fp MDPI

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.

During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

Other Names:
  • fluticasone propionate
  • Fp SPIROMAX® Inhalation Powder
Experimental: Fp MDPI 200 mcg

Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Drug: Fp MDPI

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.

During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

Other Names:
  • fluticasone propionate
  • Fp SPIROMAX® Inhalation Powder
Experimental: Fp MDPI 400 mcg

Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Drug: Fp MDPI

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.

During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

Other Names:
  • fluticasone propionate
  • Fp SPIROMAX® Inhalation Powder
Placebo Comparator: Placebo MDPI

Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Other: Placebo MDPI
Placebo multidose dry powder inhaler (MDPI) in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.
Active Comparator: Flovent Diskus 250mcg

Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.

During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Drug: albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Other Names:
  • short-acting β2-adrenergic agonists
Drug: Flovent Diskus
Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 250 mcg was used twice a day, once in the morning and evening, for a total daily dose of 500 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
Other Names:
  • Fluticasone propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period
Time Frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.

The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Time Frame: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.

Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.

The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Time Frame: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.

The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12
Time Frame: Day 1 to Week 12

The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma. Worsening asthma was defined as:

  1. clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1.

  2. any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced:

    • 3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1
    • 3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used
    • 2 or more days in which the subject experienced a nighttime asthma symptom score of >2
  3. clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization.

Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.
Day 1 to Week 12
Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods
Time Frame: Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)

The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries.

Data values are estimated means.
Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)
Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)
Time Frame: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Time Of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
Time Frame: Day 1 to Week 12
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Day 1 to Week 12
Patients With Positive Swab Test Results for Oral Candidiasis
Time Frame: Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12

Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.

This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.
Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12
24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint
Time Frame: Baseline (Day 1), Week 12, Endpoint
24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.
Baseline (Day 1), Week 12, Endpoint

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)
Time Frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.

Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.

The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model which includes data from all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)
Time Frame: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.

Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.

The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)
Time Frame: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.

The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FpS-AS-202
  • 2010-023601-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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