Phase 3
Completed N=841
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
Source: ClinicalTrials.gov NCT02980133 ↗Enrolled (actual)
841
Serious AEs
1.0%
Results posted
Mar 2020
Primary outcomePrimary: 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 — 16.8; 16.4; 18.2 percent predicted of FEV1 — p=0.285
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
16.8; 16.4; 18.2 | 0.285 |
| PRIMARY For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12 |
7.3; 13.3; 14.2 | <0.001 sig |
| SECONDARY 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 |
12.3; 28.9; 26.3; 32.0 | — |
| SECONDARY 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 |
-0.2; -0.4; -0.5; -0.4 | — |
| SECONDARY Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12 |
-0.1; -0.2; -0.2; -0.2 | — |
| SECONDARY Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period |
4.5; 5.1; 5.5; 5.4 | — |
| SECONDARY Time to First Onset of Effect |
20.0; NA; 2.0; 6.0 | — |
| SECONDARY Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period |
6; 2; 1; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02980133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.