Phase 3
Completed N=343
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
Source: ClinicalTrials.gov NCT01159912 ↗Enrolled (actual)
343
Serious AEs
2.0%
Results posted
Aug 2013
Primary outcomePrimary: Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period — 0.015; 0.161; 0.159 Liters — p=0.009
Summary
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period |
0.015; 0.161; 0.159 | 0.009 sig |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period |
6.5; 21.3; 24.3 | — |
| SECONDARY Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period |
0.4; 2.2; 4.8; -1.3; 1.5; 4.3 | — |
| SECONDARY Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period |
5.7; 13.2; 9.4; 5.0; 13.9; 9.9 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period |
10.4; 19.3; 19.2 | — |
| SECONDARY Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24 |
0.45; 0.69; 0.73; 0.51; 0.84; 0.67 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Outpatient at least 12 years of age
- Both genders; females of child bearing potential must be willing to use approved birth control method
- Pre-bronchodilator FEV1 of 40-90% predicted
- Reversibility FEV1 of at least 12% and 200mLs
- Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit
Exclusion Criteria
- History of life threatening asthma
- Respiratory infection or candidiasis
- Asthma exacerbation within 6 months prior to first visit
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drug excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
Data sourced from ClinicalTrials.gov (NCT01159912). 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.