Phase 3
Completed N=248
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
Source: ClinicalTrials.gov NCT01436071 ↗Enrolled (actual)
248
Serious AEs
0.8%
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 12-week Treatment Period — 0.038; 0.157 Liters — p=0.012
Summary
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving 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 12-week Treatment Period |
0.038; 0.157 | 0.012 sig |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period |
17.1; 28.7 | — |
| SECONDARY Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period |
19.5; 22.8 | — |
| SECONDARY Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period |
22.9; 34.5 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period |
14.0; 22.6 | — |
| SECONDARY Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period |
15; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before 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 200mls
- Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist
Exclusion Criteria
- History of life-threatening asthma exacerbation within the past 10 years
- Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
- Known or suspected allergy to study drug or materials
- Taking another investigational medication or prohibited medication during the study
- Previous treatment with inhaled fluticasone furoate in a phase II or III study
- Current smokers or former smokers with significant tobacco exposure
- Children in Care
Data sourced from ClinicalTrials.gov (NCT01436071). 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.