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AsthmaPhase 3NCT02980133

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

A Phase 3 study testing Fluticasone Propionate and Fluticasone Propionate/Salmeterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 118 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Asthma
What is being tested?
Fluticasone Propionate and Fluticasone Propionate/Salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
841 participants
Where
118 sitesin 5 countries
Study dates
28 Dec 2016to 13 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

118 sites in 5 countries.

118 sites in 5 countries

United States77 sites

  • Teva Investigational Site 13906

    Bakersfield, California, 93301

  • Teva Investigational Site 13898

    Baytown, Texas, 77521

  • Teva Investigational Site 13915

    Bellingham, Washington, 98225

  • Teva Investigational Site 13881

    Birmingham, Alabama, 35209

  • Teva Investigational Site 14673

    Boerne, Texas, 78006

  • Teva Investigational Site 13855

    Canton, Ohio, 44718

  • Teva Investigational Site 13856

    Centennial, Colorado, 80112

  • Teva Investigational Site 13871

    Charleston, South Carolina, 29407

  • Teva Investigational Site 13889

    Charleston, South Carolina, 29414

  • Teva Investigational Site 13890

    Charlotte, North Carolina, 28277

  • Teva Investigational Site 13913

    Chiefland, Florida, 32626

  • Teva Investigational Site 13910

    Colorado Springs, Colorado, 80907

  • Teva Investigational Site 13865

    Columbia, Missouri, 65203

  • Teva Investigational Site 13885

    Columbia, Missouri, 65203

  • Teva Investigational Site 14615

    Corona, California, 92883

  • Teva Investigational Site 14616

    DeLand, Florida, 32720

  • Teva Investigational Site 13892

    Downey, California, 90241

  • Teva Investigational Site 13896

    Eagle, Idaho, 83616

  • Teva Investigational Site 13867

    El Paso, Texas, 79903

  • Teva Investigational Site 13875

    Fountain Valley, California, 92708

  • Teva Investigational Site 13866

    Gainesville, Georgia, 30501

  • Teva Investigational Site 13909

    Homestead, Florida, 33030

  • Teva Investigational Site 13904

    Huntington Beach, California, 92647 6818

  • Teva Investigational Site 13877

    Huntington Beach, California, 92648

  • Teva Investigational Site 13903

    Idaho Falls, Idaho, 83402

  • Teva Investigational Site 13902

    Killeen, Texas, 76542-0969

  • Teva Investigational Site 13883

    Little Rock, Arkansas, 72205

  • Teva Investigational Site 13846

    Live Oak, Texas, 78233

  • Teva Investigational Site 14668

    Long Beach, California, 90806

  • Teva Investigational Site 13868

    Longmont, Colorado, 80501

  • Teva Investigational Site 13857

    Loxahatchee Groves, Florida, 33470

  • Teva Investigational Site 13861

    Medford, Oregon, 97504

  • Teva Investigational Site 13872

    Miami, Florida, 33134

  • Teva Investigational Site 13907

    Miami, Florida, 33134

  • Teva Investigational Site 13893

    Miami, Florida, 33142

  • Teva Investigational Site 13886

    Miami, Florida, 33155

  • Teva Investigational Site 13899

    Miami, Florida, 33175

  • Teva Investigational Site 13864

    Miami, Florida, 33176

  • Teva Investigational Site 13880

    Miami, Florida, 33176

  • Teva Investigational Site 13870

    Miami Lakes, Florida, 33014

  • Teva Investigational Site 14617

    Miami Lakes, Florida, 33015

  • Teva Investigational Site 13916

    Miami Springs, Florida, 33185

  • Teva Investigational Site 13905

    Milford, Ohio, 45150

  • Teva Investigational Site 13891

    Missoula, Montana, 59808

  • Teva Investigational Site 13914

    Napa, California, 94558

  • Teva Investigational Site 13911

    Ocala, Florida, 34471

  • Teva Investigational Site 13897

    Ocean City, New Jersey, 07712

  • Teva Investigational Site 13852

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 13879

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 13884

    Oklahoma City, Oklahoma, 73120

  • Teva Investigational Site 13887

    Overland Park, Kansas, 66210

  • Teva Investigational Site 13851

    Owensboro, Kentucky, 42301

  • Teva Investigational Site 13876

    Palmetto Bay, Florida, 33157

  • Teva Investigational Site 13918

    Paramount, California, 90723

  • Teva Investigational Site 13874

    Pittsburgh, Pennsylvania, 15241

  • Teva Investigational Site 13888

    Providence, Rhode Island, 02909

  • Teva Investigational Site 13863

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 13850

    Richmond, Virginia, 23223

  • Teva Investigational Site 13849

    Rockville, Maryland, 20850

  • Teva Investigational Site 14618

    Rolling Hills Estates, California, 90274

  • Teva Investigational Site 13912

    Roseville, California, 95661

  • Teva Investigational Site 13878

    San Antonio, Texas, 78229

  • Teva Investigational Site 14672

    San Antonio, Texas, 78229

  • Teva Investigational Site 13917

    San Antonio, Texas, 78251

  • Teva Investigational Site 13858

    Savannah, Georgia, 31406

  • Teva Investigational Site 13895

    Scottdale, Pennsylvania, 15683

  • Teva Investigational Site 13853

    Spartanburg, South Carolina, 29303

  • Teva Investigational Site 13882

    Springfield, Illinois, 62704

  • Teva Investigational Site 13847

    Stockton, California, 95207

  • Teva Investigational Site 14671

    Summerville, South Carolina, 29483

  • Teva Investigational Site 13848

    Thousand Oaks, California, 91360

  • Teva Investigational Site 13860

    Tulsa, Oklahoma, 74136

  • Teva Investigational Site 13894

    Tulsa, Oklahoma, 74136

  • Teva Investigational Site 13854

    Verona, New Jersey, 07044

  • Teva Investigational Site 13845

    Waco, Texas, 76712

  • Teva Investigational Site 13908

    Watertown, New York, 13601

  • Teva Investigational Site 13844

    Winter Park, Florida, 32789

Other trials in United States

Ukraine14 sites

  • Teva Investigational Site 58261

    Chernivtsi, 58023

  • Teva Investigational Site 58262

    Dnipropetrovsk, 49101

  • Teva Investigational Site 58269

    Ivano-Frankivsk, 76014

  • Teva Investigational Site 58270

    Kharkiv, 61093

  • Teva Investigational Site 58265

    Kryvyi Rih, 50082

  • Teva Investigational Site 58271

    Kyiv, 03115

  • Teva Investigational Site 58268

    Kyiv, 03680

  • Teva Investigational Site 58264

    Kyiv, 04050

  • Teva Investigational Site 58260

    Lviv, 79059

  • Teva Investigational Site 58259

    Odesa, 65000

  • Teva Investigational Site 58272

    Odesa, 65000

  • Teva Investigational Site 58263

    Vinnytsia, 21021

  • Teva Investigational Site 58266

    Zaporizhzhya, 69038

  • Teva Investigational Site 58267

    Zaporizhzhya, 69063

Other trials in Ukraine

Hungary10 sites

  • Teva Investigational Site 51277

    Budapest, 1083

  • Teva Investigational Site 51278

    Budapest, 1094

  • Teva Investigational Site 51272

    Budapest, H-1021

  • Teva Investigational Site 51279

    Debrecen, 4032

  • Teva Investigational Site 51271

    Dombóvár, 7200

  • Teva Investigational Site 51269

    Győr, 9023

  • Teva Investigational Site 51274

    Kaposvár, 7400

  • Teva Investigational Site 51270

    Miskolc, 3526

  • Teva Investigational Site 51276

    Szeged, 6720

  • Teva Investigational Site 51273

    Szigetvár, 7900

Other trials in Hungary

Russia9 sites

  • Teva Investigational Site 50444

    Moscow, 125412

  • Teva Investigational Site 50446

    Perm, 614066

  • Teva Investigational Site 50442

    Saint Petersburg, 191144

  • Teva Investigational Site 50447

    Saint Petersburg, 192071

  • Teva Investigational Site 50441

    Saint Petersburg, 192148

  • Teva Investigational Site 50448

    Saint Petersburg, 196191

  • Teva Investigational Site 50445

    Saint Petersburg, 196240

  • Teva Investigational Site 50443

    Saint Petersburg, 196657

  • Teva Investigational Site 50440

    Tomsk, 634050

Other trials in Russia

Georgia8 sites

  • Teva Investigational Site 81041

    Kutaisi, 4600

  • Teva Investigational Site 81047

    Tbilisi, 0119

  • Teva Investigational Site 81046

    Tbilisi, 0141

  • Teva Investigational Site 81044

    Tbilisi, 0159

  • Teva Investigational Site 81040

    Tbilisi, 0160

  • Teva Investigational Site 81045

    Tbilisi, 0171

  • Teva Investigational Site 81042

    Tbilisi, 0179

  • Teva Investigational Site 81043

    Tbilisi, 0186

Other trials in Georgia

About this study

Official title: 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.

Conditions
Asthma
Being tested
Fluticasone Propionate, Fluticasone Propionate/Salmeterol, Placebo MDPI
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone PropionateDrug

    Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

  • Fluticasone Propionate/SalmeterolDrug

    Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

  • Placebo MDPIDrug

    Matching placebo was administered via MDPI per the schedule specified in the arm.

Study groups in NCT02980133
Study groupRoleWhat they receive
Placebo MDPIPlacebo comparatorParticipants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.
Receives: Drug: Placebo MDPI
Fp MDPI 25 mcg BIDExperimentalParticipants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.
Receives: Drug: Fluticasone Propionate
Fp MDPI 50 mcg BIDExperimentalParticipants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
Receives: Drug: Fluticasone Propionate
FS MDPI 50/12.5 mcg BIDExperimentalParticipants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
Receives: Drug: Fluticasone Propionate/Salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Baseline, Week 12

  2. For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at 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.

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. 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

    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.

    Measured: Baseline, Week 1 to 12

  2. 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

    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).

    Measured: Baseline, Week 1 to 12

  3. Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 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.

    Measured: Baseline, Week 1 to 12

  4. Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period

    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.

    Measured: Baseline, Week 1 to 12

  5. Time to First Onset of Effect

    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.

    Measured: Baseline up to Week 12

  6. Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period

    Measured: Baseline up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study start28 Dec 2016
  3. Primary completion7 Apr 2019
  4. Study completion13 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980133
Sponsor's protocol ID
FSS-AS-30003
Other IDs
2016-003835-39, 2016
Status last verified
Nov 2021
First submitted
30 Nov 2016
Last updated
9 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Propionate and Fluticasone Propionate/Salmeterol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 118 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Ukraine, Hungary, Russia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02980133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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