Phase 3
Completed N=238
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Source: ClinicalTrials.gov NCT01431950 ↗Enrolled (actual)
238
Serious AEs
2.9%
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 — 0.208; 0.284 Liters
Summary
A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength 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 |
0.208; 0.284 | — |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period |
21.3; 23.1 | — |
| SECONDARY Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period |
5.9; 7.2 | — |
| SECONDARY Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period |
13.4; 13.2 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period |
17.5; 19.6 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Outpatient at least 12 years of age with 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
- Pre-bronchodilator FEV1 of 40-90% predicted
- Reversibility FEV1 of at least 12% and 200mLs
- Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit
Exclusion Criteria
- History of life threatening asthma
- Respiratory infection or candidiasis
- Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
- Concurrent respiratory disease or other disease that would confound study participation of 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 the study
- Previous treatment with FF or FF/VI in a phase II or III study
- Night shift workers
- Children in care
Data sourced from ClinicalTrials.gov (NCT01431950). 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.