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

Teva Branded Pharmaceutical Products R&D, Inc.841 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

841

Conditions

Asthma

Interventions

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (118)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Week 12

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Teva Investigational Site 13881

Birmingham, Alabama, United States

Teva Investigational Site 13883

Little Rock, Arkansas, United States

Teva Investigational Site 13906

Bakersfield, California, United States

Teva Investigational Site 14615

Corona, California, United States

Teva Investigational Site 13892

Downey, California, United States

Teva Investigational Site 13875

Fountain Valley, California, United States

Teva Investigational Site 13904

Huntington Beach, California, United States

Teva Investigational Site 13877

Huntington Beach, California, United States

Teva Investigational Site 14668

Long Beach, California, United States

Teva Investigational Site 13914

Napa, California, United States

...and 108 more locations