Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (telos)

September 3, 2019 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.

Study Type

Interventional

Enrollment (Actual)

2389

Phase

  • Phase 3

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

  • Canada
      • Quebec, Canada, G1G 3Y8
        • Research Site
      • Quebec, Canada, G1V 4G5
        • Research Site
      • Quebec, Canada, G1W 4R4
        • Research Site
      • Quebec, Canada, G3K 2P8
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6L 5X8
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • Research Site
      • Sudbury, Ontario, Canada, P3A 1W8
        • Research Site
      • Toronto, Ontario, Canada, M3J 2C5
        • Research Site
      • Windsor, Ontario, Canada, N8X 1T3
        • Research Site
      • Windsor, Ontario, Canada, N8X 5A6
        • Research Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Research Site
      • Montreal, Quebec, Canada, H1M 1B1
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
      • St Charles Borromee, Quebec, Canada, J6E 2B4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Research Site
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Research Site
  • Czechia
      • Boskovice, Czechia, 680 01
        • Research Site
      • Brandys nad Labem, Czechia, 250 01
        • Research Site
      • Jindrichuv Hradec, Czechia, 37701
        • Research Site
      • Liberec, Czechia, 525947
        • Research Site
      • Lovosice, Czechia, 410 02
        • Research Site
      • Novy Bor, Czechia, 473 01
        • Research Site
      • Ostrava-Hrabuvka, Czechia, 700 30
        • Research Site
      • Ostrava-Poruba, Czechia, 708 68
        • Research Site
      • Prague, Czechia, 15000
        • Research Site
      • Praha, Czechia, 140 59
        • Research Site
      • Praha, Czechia, 140 00
        • Research Site
      • Praha 6, Czechia, 16900
        • Research Site
      • Praha 9, Czechia, 190 00
        • Research Site
      • Rokycany, Czechia, 337 22
        • Research Site
      • Strakonice, Czechia, 38601
        • Research Site
      • Teplice, Czechia, 415 01
        • Research Site
      • Varnsdorf, Czechia, 407 47
        • Research Site
      • Zatec, Czechia, 43801
        • Research Site
  • Germany
      • Bamberg, Germany, 96049
        • Research Site
      • Berlin, Germany, 14059
        • Research Site
      • Berlin, Germany, 10119
        • Research Site
      • Berlin, Germany, 10629
        • Research Site
      • Berlin, Germany, 10787
        • Research Site
      • Berlin, Germany, 12157
        • Research Site
      • Berlin, Germany, 13156
        • Research Site
      • Darmstadt, Germany, 64283
        • Research Site
      • Essen, Germany, 45355
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Hamburg, Germany, 20354
        • Research Site
      • Hamburg, Germany, 20253
        • Research Site
      • Köln, Germany, 51069
        • Research Site
      • Leipzig, Germany, 04109
        • Research Site
      • Leipzig, Germany, 04207
        • Research Site
      • Lübeck, Germany, 23552
        • Research Site
      • Rodgau-Dudenhofen, Germany, 63110
        • Research Site
      • Schwerin, Germany, 19055
        • Research Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Research Site
      • Budapest, Hungary, 1135
        • Research Site
      • Cegléd, Hungary, 2700
        • Research Site
      • Csorna, Hungary, 9300
        • Research Site
      • Gödöllő, Hungary, 2100
        • Research Site
      • Hajdúnánás, Hungary, 4080
        • Research Site
      • Hatvan, Hungary, 3000
        • Research Site
      • Komárom, Hungary, 2900
        • Research Site
      • Makó, Hungary, 6900
        • Research Site
      • Miskolc, Hungary, 3529
        • Research Site
      • Nyíregyháza, Hungary, 4400
        • Research Site
      • Pécs, Hungary, 7626
        • Research Site
      • Pécs, Hungary, 7635
        • Research Site
      • Siófok, Hungary, 8600
        • Research Site
      • Szeged, Hungary, H-6722
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
      • Százhalombatta, Hungary, 2440
        • Research Site
  • Korea, Republic of
      • Anyang-si, Korea, Republic of, 14068
        • Research Site
      • Busan, Korea, Republic of, 49201
        • Research Site
      • Incheon, Korea, Republic of, 21431
        • Research Site
      • Jeonju-si, Korea, Republic of, 54907
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 03181
        • Research Site
      • Seoul, Korea, Republic of, 02841
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Seoul, Korea, Republic of, 08308
        • Research Site
      • Seoul, Korea, Republic of, 02559
        • Research Site
      • Seoul, Korea, Republic of, 04401
        • Research Site
      • Seoul, Korea, Republic of, 04551
        • Research Site
  • Poland
      • Białystok, Poland, 15-003
        • Research Site
      • Białystok, Poland, 15-044
        • Research Site
      • Białystok, Poland, 15-430
        • Research Site
      • Bielsko-Biała, Poland, 43-300
        • Research Site
      • Chełm, Poland, 22-100
        • Research Site
      • Elbląg, Poland, 82-300
        • Research Site
      • Gdańsk, Poland, 80-952
        • Research Site
      • Grudziądz, Poland, 86-300
        • Research Site
      • Katowice, Poland, 40-648
        • Research Site
      • Kościan, Poland, 64-000
        • Research Site
      • Kraków, Poland, 30-901
        • Research Site
      • Kraków, Poland, 31-159
        • Research Site
      • Legnica, Poland, 59-220
        • Research Site
      • Lublin, Poland, 20-093
        • Research Site
      • Nowy Duninow, Poland, 09-505
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Research Site
      • Ostrów Wielkopolski, Poland, 63-400
        • Research Site
      • Piekary Śląskie, Poland, 41-94O
        • Research Site
      • Pila, Poland, 64-920
        • Research Site
      • Poznań, Poland, 60-685
        • Research Site
      • Poznań, Poland, 60-693
        • Research Site
      • Poznań, Poland, 60-823
        • Research Site
      • Proszowice, Poland, 32-100
        • Research Site
      • Puławy, Poland, 24-100
        • Research Site
      • Ruda Slaska, Poland, 41-709
        • Research Site
      • Rzeszów, Poland, 35-051
        • Research Site
      • Rzeszów, Poland, 35-205
        • Research Site
      • Siedlce, Poland, 08-110
        • Research Site
      • Sochaczew, Poland, 96-500
        • Research Site
      • Suwałki, Poland, 16-400
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
      • Tarnów, Poland, 33-100
        • Research Site
      • Trzebnica, Poland, 55-100
        • Research Site
      • Warszawa, Poland, 01-518
        • Research Site
      • Warszawa, Poland, 02-777
        • Research Site
      • Wieluń, Poland, 98-300
        • Research Site
      • Wołomin, Poland, 05-200
        • Research Site
      • Wrocław, Poland, 53-301
        • Research Site
      • Zabrze, Poland, 41-800
        • Research Site
      • Zamość, Poland, 22-400
        • Research Site
      • Łódź, Poland, 90-141
        • Research Site
      • Łódź, Poland, 91-363
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Research Site
      • Chelyabinsk, Russian Federation, 454106
        • Research Site
      • Ivanovo, Russian Federation, 153005
        • Research Site
      • Izhevsk, Russian Federation, 426035
        • Research Site
      • Kazan, Russian Federation, 420008
        • Research Site
      • Kazan, Russian Federation, 420012
        • Research Site
      • Kirov, Russian Federation, 610027
        • Research Site
      • Moscow, Russian Federation, 123423
        • Research Site
      • Moscow, Russian Federation, 119991
        • Research Site
      • Moscow, Russian Federation, 123995
        • Research Site
      • Moscow, Russian Federation, 125315
        • Research Site
      • Moscow, Russian Federation, 129090
        • Research Site
      • Nizhny Novgorod, Russian Federation, 603126
        • Research Site
      • Novosibirsk, Russian Federation, 630008
        • Research Site
      • Novosibirsk, Russian Federation, 630051
        • Research Site
      • Novosibirsk, Russian Federation, 630084
        • Research Site
      • Novosibirsk, Russian Federation, 630087
        • Research Site
      • Omsk, Russian Federation, 644043
        • Research Site
      • Omsk, Russian Federation, 644112
        • Research Site
      • Penza, Russian Federation, 440026
        • Research Site
      • Penza, Russian Federation, 440067
        • Research Site
      • Perm, Russian Federation, 614000
        • Research Site
      • Pytigorsk, Russian Federation, 357538
        • Research Site
      • Rostov-na-Donu, Russian Federation, 344068
        • Research Site
      • Ryazan, Russian Federation, 390026
        • Research Site
      • Saint Petersburg, Russian Federation, 194044
        • Research Site
      • Saint Petersburg, Russian Federation, 194354
        • Research Site
      • Saint Petersburg, Russian Federation, 196601
        • Research Site
      • Saint Petersburg, Russian Federation, 197342
        • Research Site
      • Saint Petersburg, Russian Federation, 198260
        • Research Site
      • Saint-Petersburg, Russian Federation, 194291
        • Research Site
      • Saint-Petersburg, Russian Federation, 196084
        • Research Site
      • Saint-Petersburg, Russian Federation, 196143
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • Saratov, Russian Federation, 410012
        • Research Site
      • Smolensk, Russian Federation, 214006
        • Research Site
      • Smolensk, Russian Federation, 214019
        • Research Site
      • St-Petersburg, Russian Federation, 193231
        • Research Site
      • St. Petersburg, Russian Federation, 196247
        • Research Site
      • St. Petersburg, Russian Federation, 197022
        • Research Site
      • St. Petersburg, Russian Federation, 197089
        • Research Site
      • Ulyanovsk, Russian Federation, 432009
        • Research Site
      • Vladimir, Russian Federation, 600023
        • Research Site
      • Voronezh, Russian Federation, 394066
        • Research Site
      • Yaroslavl, Russian Federation, 150002
        • Research Site
      • Yaroslavl, Russian Federation, 150062
        • Research Site
      • Yekaterinburg, Russian Federation, 620039
        • Research Site
      • Yekaterinburg, Russian Federation, 620149
        • Research Site
  • United States
    • Alabama
      • Athens, Alabama, United States, 35611
        • Research Site
      • Birmingham, Alabama, United States, 35243
        • Research Site
      • Dothan, Alabama, United States, 36305
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Research Site
      • Phoenix, Arizona, United States, 85020
        • Research Site
      • Tucson, Arizona, United States, 85745
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • Palm Springs, California, United States, 92262
        • Research Site
      • Sacramento, California, United States, 95823
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Research Site
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
      • Littleton, Colorado, United States, 80127
        • Research Site
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Hialeah, Florida, United States, 33016
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33134
        • Research Site
      • Miami, Florida, United States, 33175
        • Research Site
      • Panama City, Florida, United States, 32405
        • Research Site
      • Port Orange, Florida, United States, 32129
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Winter Park, Florida, United States, 32789-4681
        • Research Site
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Research Site
    • Maryland
      • Towson, Maryland, United States, 21204
        • Research Site
      • Westminster, Maryland, United States, 21157
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
      • Fridley, Minnesota, United States, 55432
        • Research Site
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Woodbury, Minnesota, United States, 55125
        • Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Research Site
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89118
        • Research Site
    • New York
      • Jackson Heights, New York, United States, 11236
        • Research Site
      • Larchmont, New York, United States, 10803
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Huntersville, North Carolina, United States, 28078
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
      • Dayton, Ohio, United States, 45459
        • Research Site
      • Dublin, Ohio, United States, 43016
        • Research Site
      • Grove City, Ohio, United States, 43123
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Easley, South Carolina, United States, 29640
        • Research Site
      • Gaffney, South Carolina, United States, 29341
        • Research Site
      • Greenville, South Carolina, United States, 29615
        • Research Site
      • Indian Land, South Carolina, United States, 29707
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Seneca, South Carolina, United States, 29678
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
      • Union, South Carolina, United States, 29379
        • Research Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
    • Texas
      • Channelview, Texas, United States, 77530
        • Research Site
      • Live Oak, Texas, United States, 78233
        • Research Site
      • New Braunfels, Texas, United States, 78130
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78212
        • Research Site
      • Sugar Land, Texas, United States, 77479
        • Research Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Research Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Research Site
      • Bellevue, Washington, United States, 98007
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Give their signed written informed consent to participate
  2. Are at least 40 years of age and no older than 80 years
  3. COPD patients who are symptomatic
  4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

Exclusion Criteria:

  1. Current diagnosis of asthma,
  2. COPD due to α1-Antitrypsin Deficiency
  3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
  4. Long-term-oxygen therapy (≥ 12 hours a day).

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: BFF MDI 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI 320/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
Experimental: BFF MDI 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI 160/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
Experimental: FF MDI 9.6 μg
Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID
Drug: FF MDI 9.6 μg
Blinded Treatment
Other Names:
  • Formoterol Fumarate Inhalation Aerosol
Experimental: BD MDI 320 μg
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BD MDI 320 μg
Blinded Treatment
Other Names:
  • Budesonide Inhalation Aerosol
Other: Symbicort® TBH 400/12 μg
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
Drug: Symbicort® TBH 400/12 μg BID
Open Label
Other Names:
  • Symbicort® Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Time Frame: at Week 24
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
at Week 24
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Time Frame: at Week 24
Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Time Frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).
over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
Time Frame: at Week 24
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Time Frame: at Week 24
Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
at Week 24
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Time Frame: at Week 24
Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Time Frame: over 24 Weeks
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)
over 24 Weeks
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Time Frame: Day 1 - 5 Minutes
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 5 Minutes
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Time Frame: Day 1 - 15 Minutes
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 15 Minutes
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Time Frame: Day 1 - 30 Minutes
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 30 Minutes
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Time Frame: Day 1 - 1 Hour
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 1 Hour
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Time Frame: Day 1 - 2 Hours
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 2 Hours
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Time Frame: Day 1 - 4 Hours
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Day 1 - 4 Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substudy: 12-hour PFT Endpoint FEV1 AUC0-12
Time Frame: at Week 12
Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.
at Week 12

Collaborators and Investigators

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

Sponsor

Pearl Therapeutics, Inc.

Publications and helpful links

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General Publications

Helpful Links

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 (Actual)

May 31, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT009002

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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