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

NCT02980133 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: FSS-AS-300032016-003835-39
• Study Type: interventional
• Target: 841
• Locations: 5 countries
• Sites: 118

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 12

• 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.

  Baseline, Week 12

Secondary Outcomes (6)

• 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

  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

  Baseline, Week 1 to 12

• Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12

  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

  Baseline, Week 1 to 12

• Time to First Onset of Effect

  Baseline up to Week 12

Study Arms (4)

Placebo MDPI

PLACEBO COMPARATOR

Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.

Drug: Placebo MDPI

Fp MDPI 25 mcg BID

EXPERIMENTAL

Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.

Drug: Fluticasone Propionate

Fp MDPI 50 mcg BID

EXPERIMENTAL

Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.

Drug: Fluticasone Propionate

FS MDPI 50/12.5 mcg BID

EXPERIMENTAL

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.

Drug: Fluticasone Propionate/Salmeterol

Interventions

Fluticasone Propionate DRUG

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

Fp MDPI 25 mcg BID; Fp MDPI 50 mcg BID

Fluticasone Propionate/Salmeterol DRUG

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

FS MDPI 50/12.5 mcg BID

Placebo MDPI DRUG

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

Placebo MDPI

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (118)

Teva Investigational Site 13881

Birmingham, Alabama, 35209, United States

Location

Teva Investigational Site 13883

Little Rock, Arkansas, 72205, United States

Location

Teva Investigational Site 13906

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 14615

Corona, California, 92883, United States

Location

Teva Investigational Site 13892

Downey, California, 90241, United States

Location

Teva Investigational Site 13875

Fountain Valley, California, 92708, United States

Location

Teva Investigational Site 13904

Huntington Beach, California, 92647 6818, United States

Location

Teva Investigational Site 13877

Huntington Beach, California, 92648, United States

Location

Teva Investigational Site 14668

Long Beach, California, 90806, United States

Location

Teva Investigational Site 13914

Napa, California, 94558, United States

Location

Teva Investigational Site 13918

Paramount, California, 90723, United States

Location

Teva Investigational Site 14618

Rolling Hills Estates, California, 90274, United States

Location

Teva Investigational Site 13912

Roseville, California, 95661, United States

Location

Teva Investigational Site 13847

Stockton, California, 95207, United States

Location

Teva Investigational Site 13848

Thousand Oaks, California, 91360, United States

Location

Teva Investigational Site 13856

Centennial, Colorado, 80112, United States

Location

Teva Investigational Site 13910

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 13868

Longmont, Colorado, 80501, United States

Location

Teva Investigational Site 13913

Chiefland, Florida, 32626, United States

Location

Teva Investigational Site 14616

DeLand, Florida, 32720, United States

Location

Teva Investigational Site 13909

Homestead, Florida, 33030, United States

Location

Teva Investigational Site 13857

Loxahatchee Groves, Florida, 33470, United States

Location

Teva Investigational Site 13872

Miami, Florida, 33134, United States

Location

Teva Investigational Site 13907

Miami, Florida, 33134, United States

Location

Teva Investigational Site 13893

Miami, Florida, 33142, United States

Location

Teva Investigational Site 13886

Miami, Florida, 33155, United States

Location

Teva Investigational Site 13899

Miami, Florida, 33175, United States

Location

Teva Investigational Site 13864

Miami, Florida, 33176, United States

Location

Teva Investigational Site 13880

Miami, Florida, 33176, United States

Location

Teva Investigational Site 13870

Miami Lakes, Florida, 33014, United States

Location

Teva Investigational Site 14617

Miami Lakes, Florida, 33015, United States

Location

Teva Investigational Site 13916

Miami Springs, Florida, 33185, United States

Location

Teva Investigational Site 13911

Ocala, Florida, 34471, United States

Location

Teva Investigational Site 13876

Palmetto Bay, Florida, 33157, United States

Location

Teva Investigational Site 13844

Winter Park, Florida, 32789, United States

Location

Teva Investigational Site 13866

Gainesville, Georgia, 30501, United States

Location

Teva Investigational Site 13858

Savannah, Georgia, 31406, United States

Location

Teva Investigational Site 13896

Eagle, Idaho, 83616, United States

Location

Teva Investigational Site 13903

Idaho Falls, Idaho, 83402, United States

Location

Teva Investigational Site 13882

Springfield, Illinois, 62704, United States

Location

Teva Investigational Site 13887

Overland Park, Kansas, 66210, United States

Location

Teva Investigational Site 13851

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 13849

Rockville, Maryland, 20850, United States

Location

Teva Investigational Site 13865

Columbia, Missouri, 65203, United States

Location

Teva Investigational Site 13885

Columbia, Missouri, 65203, United States

Location

Teva Investigational Site 13891

Missoula, Montana, 59808, United States

Location

Teva Investigational Site 13897

Ocean City, New Jersey, 07712, United States

Location

Teva Investigational Site 13854

Verona, New Jersey, 07044, United States

Location

Teva Investigational Site 13908

Watertown, New York, 13601, United States

Location

Teva Investigational Site 13890

Charlotte, North Carolina, 28277, United States

Location

Teva Investigational Site 13863

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 13855

Canton, Ohio, 44718, United States

Location

Teva Investigational Site 13905

Milford, Ohio, 45150, United States

Location

Teva Investigational Site 13852

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 13879

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 13884

Oklahoma City, Oklahoma, 73120, United States

Location

Teva Investigational Site 13860

Tulsa, Oklahoma, 74136, United States

Location

Teva Investigational Site 13894

Tulsa, Oklahoma, 74136, United States

Location

Teva Investigational Site 13861

Medford, Oregon, 97504, United States

Location

Teva Investigational Site 13874

Pittsburgh, Pennsylvania, 15241, United States

Location

Teva Investigational Site 13895

Scottdale, Pennsylvania, 15683, United States

Location

Teva Investigational Site 13888

Providence, Rhode Island, 02909, United States

Location

Teva Investigational Site 13871

Charleston, South Carolina, 29407, United States

Location

Teva Investigational Site 13889

Charleston, South Carolina, 29414, United States

Location

Teva Investigational Site 13853

Spartanburg, South Carolina, 29303, United States

Location

Teva Investigational Site 14671

Summerville, South Carolina, 29483, United States

Location

Teva Investigational Site 13898

Baytown, Texas, 77521, United States

Location

Teva Investigational Site 14673

Boerne, Texas, 78006, United States

Location

Teva Investigational Site 13867

El Paso, Texas, 79903, United States

Location

Teva Investigational Site 13902

Killeen, Texas, 76542-0969, United States

Location

Teva Investigational Site 13846

Live Oak, Texas, 78233, United States

Location

Teva Investigational Site 13878

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 14672

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 13917

San Antonio, Texas, 78251, United States

Location

Teva Investigational Site 13845

Waco, Texas, 76712, United States

Location

Teva Investigational Site 13850

Richmond, Virginia, 23223, United States

Location

Teva Investigational Site 13915

Bellingham, Washington, 98225, United States

Location

Teva Investigational Site 81041

Kutaisi, 4600, Georgia

Location

Teva Investigational Site 81047

Tbilisi, 0119, Georgia

Location

Teva Investigational Site 81046

Tbilisi, 0141, Georgia

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Teva Investigational Site 81044

Tbilisi, 0159, Georgia

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Teva Investigational Site 81040

Tbilisi, 0160, Georgia

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Teva Investigational Site 81045

Tbilisi, 0171, Georgia

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Teva Investigational Site 81042

Tbilisi, 0179, Georgia

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Teva Investigational Site 81043

Tbilisi, 0186, Georgia

Location

Teva Investigational Site 51277

Budapest, 1083, Hungary

Location

Teva Investigational Site 51278

Budapest, 1094, Hungary

Location

Teva Investigational Site 51272

Budapest, H-1021, Hungary

Location

Teva Investigational Site 51279

Debrecen, 4032, Hungary

Location

Teva Investigational Site 51271

Dombóvár, 7200, Hungary

Location

Teva Investigational Site 51269

Győr, 9023, Hungary

Location

Teva Investigational Site 51274

Kaposvár, 7400, Hungary

Location

Teva Investigational Site 51270

Miskolc, 3526, Hungary

Location

Teva Investigational Site 51276

Szeged, 6720, Hungary

Location

Teva Investigational Site 51273

Szigetvár, 7900, Hungary

Location

Teva Investigational Site 50444

Moscow, 125412, Russia

Location

Teva Investigational Site 50446

Perm, 614066, Russia

Location

Teva Investigational Site 50442

Saint Petersburg, 191144, Russia

Location

Teva Investigational Site 50447

Saint Petersburg, 192071, Russia

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Teva Investigational Site 50441

Saint Petersburg, 192148, Russia

Location

Teva Investigational Site 50448

Saint Petersburg, 196191, Russia

Location

Teva Investigational Site 50445

Saint Petersburg, 196240, Russia

Location

Teva Investigational Site 50443

Saint Petersburg, 196657, Russia

Location

Teva Investigational Site 50440

Tomsk, 634050, Russia

Location

Teva Investigational Site 58261

Chernivtsi, 58023, Ukraine

Location

Teva Investigational Site 58262

Dnipropetrovsk, 49101, Ukraine

Location

Teva Investigational Site 58269

Ivano-Frankivsk, 76014, Ukraine

Location

Teva Investigational Site 58270

Kharkiv, 61093, Ukraine

Location

Teva Investigational Site 58265

Kryvyi Rih, 50082, Ukraine

Location

Teva Investigational Site 58271

Kyiv, 03115, Ukraine

Location

Teva Investigational Site 58268

Kyiv, 03680, Ukraine

Location

Teva Investigational Site 58264

Kyiv, 04050, Ukraine

Location

Teva Investigational Site 58260

Lviv, 79059, Ukraine

Location

Teva Investigational Site 58259

Odesa, 65000, Ukraine

Location

Teva Investigational Site 58272

Odesa, 65000, Ukraine

Location

Teva Investigational Site 58263

Vinnytsia, 21021, Ukraine

Location

Teva Investigational Site 58267

Zaporizhzhia, 69063, Ukraine

Location

Teva Investigational Site 58266

Zaporizhzhya, 69038, Ukraine

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: December 28, 2016
• Primary Completion: April 7, 2019
• Study Completion: April 13, 2019
• Last Updated: November 9, 2021
• Results First Posted: March 18, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (77); HU (10); UA (14); RU (9); GE (8)