Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma

This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.

Study Overview

Study Type

Interventional

Enrollment (Actual)

841

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

      • Kutaisi, Georgia, 4600
        • Teva Investigational Site 81041
      • Tbilisi, Georgia, 0119
        • Teva Investigational Site 81047
      • Tbilisi, Georgia, 0141
        • Teva Investigational Site 81046
      • Tbilisi, Georgia, 0159
        • Teva Investigational Site 81044
      • Tbilisi, Georgia, 0160
        • Teva Investigational Site 81040
      • Tbilisi, Georgia, 0171
        • Teva Investigational Site 81045
      • Tbilisi, Georgia, 0179
        • Teva Investigational Site 81042
      • Tbilisi, Georgia, 0186
        • Teva Investigational Site 81043
      • Budapest, Hungary, 1083
        • Teva Investigational Site 51277
      • Budapest, Hungary, 1094
        • Teva Investigational Site 51278
      • Budapest, Hungary, H-1021
        • Teva Investigational Site 51272
      • Debrecen, Hungary, 4032
        • Teva Investigational Site 51279
      • Dombovar, Hungary, 7200
        • Teva Investigational Site 51271
      • Gyor, Hungary, 9023
        • Teva Investigational Site 51269
      • Kaposvar, Hungary, 7400
        • Teva Investigational Site 51274
      • Miskolc, Hungary, 3526
        • Teva Investigational Site 51270
      • Szeged, Hungary, 6720
        • Teva Investigational Site 51276
      • Szigetvar, Hungary, 7900
        • Teva Investigational Site 51273
      • Moscow, Russian Federation, 125412
        • Teva Investigational Site 50444
      • Perm, Russian Federation, 614066
        • Teva Investigational Site 50446
      • Saint Petersburg, Russian Federation, 196240
        • Teva Investigational Site 50445
      • Saint Petersburg, Russian Federation, 196657
        • Teva Investigational Site 50443
      • Saint-Petersburg, Russian Federation, 191144
        • Teva Investigational Site 50442
      • Saint-Petersburg, Russian Federation, 192071
        • Teva Investigational Site 50447
      • Saint-Petersburg, Russian Federation, 192148
        • Teva Investigational Site 50441
      • Saint-Petersburg, Russian Federation, 196191
        • Teva Investigational Site 50448
      • Tomsk, Russian Federation, 634050
        • Teva Investigational Site 50440
      • Chernivtsi, Ukraine, 58023
        • Teva Investigational Site 58261
      • Dnipropetrovsk, Ukraine, 49101
        • Teva Investigational Site 58262
      • Ivano-Frankivsk, Ukraine, 76014
        • Teva Investigational Site 58269
      • Kharkiv, Ukraine, 61093
        • Teva Investigational Site 58270
      • Kryvyi Rih, Ukraine, 50082
        • Teva Investigational Site 58265
      • Kyiv, Ukraine, 03115
        • Teva Investigational Site 58271
      • Kyiv, Ukraine, 03680
        • Teva Investigational Site 58268
      • Kyiv, Ukraine, 04050
        • Teva Investigational Site 58264
      • Lviv, Ukraine, 79059
        • Teva Investigational Site 58260
      • Odesa, Ukraine, 65000
        • Teva Investigational Site 58259
      • Odessa, Ukraine, 65000
        • Teva Investigational Site 58272
      • Vinnytsya, Ukraine, 21021
        • Teva Investigational Site 58263
      • Zaporizhzhia, Ukraine, 69063
        • Teva Investigational Site 58267
      • Zaporizhzhya, Ukraine, 69038
        • Teva Investigational Site 58266
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Teva Investigational Site 13881
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Teva Investigational Site 13883
    • California
      • Bakersfield, California, United States, 93301
        • Teva Investigational Site 13906
      • Corona, California, United States, 92883
        • Teva Investigational Site 14615
      • Downey, California, United States, 90241
        • Teva Investigational Site 13892
      • Fountain Valley, California, United States, 92708
        • Teva Investigational Site 13875
      • Huntington Beach, California, United States, 92647 6818
        • Teva Investigational Site 13904
      • Huntington Beach, California, United States, 92648
        • Teva Investigational Site 13877
      • Long Beach, California, United States, 90806
        • Teva Investigational Site 14668
      • Napa, California, United States, 94558
        • Teva Investigational Site 13914
      • Paramount, California, United States, 90723
        • Teva Investigational Site 13918
      • Rolling Hills Estates, California, United States, 90274
        • Teva Investigational Site 14618
      • Roseville, California, United States, 95661
        • Teva Investigational Site 13912
      • Stockton, California, United States, 95207
        • Teva Investigational Site 13847
      • Thousand Oaks, California, United States, 91360
        • Teva Investigational Site 13848
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Teva Investigational Site 13856
      • Colorado Springs, Colorado, United States, 80907
        • Teva Investigational Site 13910
      • Longmont, Colorado, United States, 80501
        • Teva Investigational Site 13868
    • Florida
      • Chiefland, Florida, United States, 32626
        • Teva Investigational Site 13913
      • DeLand, Florida, United States, 32720
        • Teva Investigational Site 14616
      • Homestead, Florida, United States, 33030
        • Teva Investigational Site 13909
      • Loxahatchee Groves, Florida, United States, 33470
        • Teva Investigational Site 13857
      • Miami, Florida, United States, 33134
        • Teva Investigational Site 13872
      • Miami, Florida, United States, 33134
        • Teva Investigational Site 13907
      • Miami, Florida, United States, 33142
        • Teva Investigational Site 13893
      • Miami, Florida, United States, 33155
        • Teva Investigational Site 13886
      • Miami, Florida, United States, 33175
        • Teva Investigational Site 13899
      • Miami, Florida, United States, 33176
        • Teva Investigational Site 13864
      • Miami, Florida, United States, 33176
        • Teva Investigational Site 13880
      • Miami Lakes, Florida, United States, 33014
        • Teva Investigational Site 13870
      • Miami Lakes, Florida, United States, 33015
        • Teva Investigational Site 14617
      • Miami Springs, Florida, United States, 33185
        • Teva Investigational Site 13916
      • Ocala, Florida, United States, 34471
        • Teva Investigational Site 13911
      • Palmetto Bay, Florida, United States, 33157
        • Teva Investigational Site 13876
      • Winter Park, Florida, United States, 32789
        • Teva Investigational Site 13844
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Teva Investigational Site 13866
      • Savannah, Georgia, United States, 31406
        • Teva Investigational Site 13858
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Teva Investigational Site 13896
      • Idaho Falls, Idaho, United States, 83402
        • Teva Investigational Site 13903
    • Illinois
      • Springfield, Illinois, United States, 62704
        • Teva Investigational Site 13882
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Teva Investigational Site 13887
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Teva Investigational Site 13851
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Teva Investigational Site 13849
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Teva Investigational Site 13865
      • Columbia, Missouri, United States, 65203
        • Teva Investigational Site 13885
    • Montana
      • Missoula, Montana, United States, 59808
        • Teva Investigational Site 13891
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Teva Investigational Site 13897
      • Verona, New Jersey, United States, 07044
        • Teva Investigational Site 13854
    • New York
      • Watertown, New York, United States, 13601
        • Teva Investigational Site 13908
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Teva Investigational Site 13890
      • Raleigh, North Carolina, United States, 27607
        • Teva Investigational Site 13863
    • Ohio
      • Canton, Ohio, United States, 44718
        • Teva Investigational Site 13855
      • Milford, Ohio, United States, 45150
        • Teva Investigational Site 13905
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Teva Investigational Site 13852
      • Oklahoma City, Oklahoma, United States, 73112
        • Teva Investigational Site 13879
      • Oklahoma City, Oklahoma, United States, 73120
        • Teva Investigational Site 13884
      • Tulsa, Oklahoma, United States, 74136
        • Teva Investigational Site 13860
      • Tulsa, Oklahoma, United States, 74136
        • Teva Investigational Site 13894
    • Oregon
      • Medford, Oregon, United States, 97504
        • Teva Investigational Site 13861
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Teva Investigational Site 13874
      • Scottdale, Pennsylvania, United States, 15683
        • Teva Investigational Site 13895
    • Rhode Island
      • Providence, Rhode Island, United States, 02909
        • Teva Investigational Site 13888
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Teva Investigational Site 13871
      • Charleston, South Carolina, United States, 29414
        • Teva Investigational Site 13889
      • Spartanburg, South Carolina, United States, 29303
        • Teva Investigational Site 13853
      • Summerville, South Carolina, United States, 29483
        • Teva Investigational Site 14671
    • Texas
      • Baytown, Texas, United States, 77521
        • Teva Investigational Site 13898
      • Boerne, Texas, United States, 78006
        • Teva Investigational Site 14673
      • El Paso, Texas, United States, 79903
        • Teva Investigational Site 13867
      • Killeen, Texas, United States, 76542-0969
        • Teva Investigational Site 13902
      • Live Oak, Texas, United States, 78233
        • Teva Investigational Site 13846
      • San Antonio, Texas, United States, 78229
        • Teva Investigational Site 13878
      • San Antonio, Texas, United States, 78229
        • Teva Investigational Site 14672
      • San Antonio, Texas, United States, 78251
        • Teva Investigational Site 13917
      • Waco, Texas, United States, 76712
        • Teva Investigational Site 13845
    • Virginia
      • Richmond, Virginia, United States, 23223
        • Teva Investigational Site 13850
    • Washington
      • Bellingham, Washington, United States, 98225
        • Teva Investigational Site 13915

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

4 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH).
  • The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV).
  • The participant's persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible.
  • The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol.
  • The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device.
  • All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) inhalation aerosol at the SV for use as needed for the duration of the study.

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The participant has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • The participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participant's last study-related visit.
  • The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose).
  • The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
  • The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco).
  • The participant has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.
  • The participant has used immunosuppressive medications within 30 days before the SV.
  • The participant has untreated oral candidiasis at the SV. Participants with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.
  • The participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
  • The participant is an immediate relative of an employee of the clinical investigational center.
  • A member of the participant's household is participating in the study at the same time.
  • Vulnerable participants (that is, people kept in detention) are excluded from participation.

    • Additional criteria apply, please contact the investigator for more information

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo MDPI
Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.
Matching placebo was administered via MDPI per the schedule specified in the arm.
EXPERIMENTAL: Fp MDPI 25 mcg BID
Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.
Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.
EXPERIMENTAL: Fp MDPI 50 mcg BID
Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.
EXPERIMENTAL: FS MDPI 50/12.5 mcg BID
Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessments on Week 12 at the investigational center.
Baseline, Week 12
For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning percent predicted FEV1 measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning FEV1 values divided by the number of nonmissing assessments.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period
Time Frame: Baseline, Week 1 to 12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Morning PEF was determined in the morning, before administration of IMP or rescue medications. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments.
Baseline, Week 1 to 12
Change From Baseline in the Weekly Average of Total Daily (24 Hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1 Through 12
Time Frame: Baseline, Week 1 to 12
Participants recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each morning and evening in the electronic patient diary. An entry of 0 inhalations indicated no rescue medication was needed. To calculate the total daily use of albuterol/salbutamol inhalation aerosol (number of inhalations), the electronic patient diary entry on randomization visit (Baseline [Day 1]) was defined as the first day of analysis. The weekly average of the total daily inhalations was the average based on the available data for that week. The average was calculated as the sum of total daily inhalations over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and standard error (SE) were obtained using mixed model for repeated measures (MMRM).
Baseline, Week 1 to 12
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12
Time Frame: Baseline, Week 1 to 12
Asthma symptom scores were recorded in the patient diary. Each participant assessed the symptoms of cough, wheeze, shortness of breath, and chest tightness and entered a single score that was inclusive of all symptoms. Daytime Symptom Score (determined in the evening) ranged from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. Nighttime Symptom Score (determined in the morning) ranged from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score was the average of the daytime and nighttime scores. The total daily asthma symptom score ranged from 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night. The weekly average was calculated as the sum of total daily asthma symptom scores over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and SE were obtained using MMRM.
Baseline, Week 1 to 12
Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period
Time Frame: Baseline, Week 1 to 12
C-ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The first 4 items of the test were completed by the participant, while the last 3 items were completed by the participant's parents/legal guardians/caregivers. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranging from 0 to 27. These scores spanned the continuum of poor control of asthma (score ≤5) to complete control of asthma (score ≥25), with a cut off score of 19 indicating participants with poorly controlled asthma. LS mean and SE were obtained using MMRM.
Baseline, Week 1 to 12
Time to First Onset of Effect
Time Frame: Baseline up to Week 12
The time to first onset of effect, defined as the first decrease from baseline in daily rescue medication use, was calculated based on the number of inhalations of rescue medication (albuterol/salbutamol hydrofluoroalkane metered-dose inhaler [HFA MDI] [90 mcg ex actuator] or equivalent) recorded by the participant each morning and evening in the patient diary built into the handheld device.
Baseline up to Week 12
Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period
Time Frame: Baseline up to Week 12
Baseline up to Week 12

Collaborators and Investigators

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

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)

December 28, 2016

Primary Completion (ACTUAL)

April 7, 2019

Study Completion (ACTUAL)

April 13, 2019

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (ESTIMATE)

December 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

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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