Phase 3
Completed N=351
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
Source: ClinicalTrials.gov NCT01436110 ↗Enrolled (actual)
351
Serious AEs
1.2%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period — 0.089; 0.126; 0.191 Liters — p=0.430
Summary
A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period |
0.089; 0.126; 0.191 | 0.430 |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period |
21.1; 28.9; 31.7 | — |
| SECONDARY Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period |
7.6; 24.9; 12.0 | — |
| SECONDARY Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period |
10.8; 30.0; 21.4 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period |
16.8; 25.1; 24.3 | — |
| SECONDARY Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period |
23; 14; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
- Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
- Pre-bronchodilator FEV1 of at least 60% predicted
- FEV1 reversibility of at least 12% and 200ml
- Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist
Exclusion Criteria
- History of life-threatening asthma exacerbation with the past 10 years
- Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
- Known or suspected allergy to study medication or materials
- Taking another investigational medication or prohibited medication during the study
- Current smokers or former smokers with significant tobacco exposure
- Previous treatment with fluticasone furoate in a phase II or III study
- Children in Care
Data sourced from ClinicalTrials.gov (NCT01436110). 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.