Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 11/11/2017 |
Start Date: | June 30, 2010 |
End Date: | January 16, 2012 |
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.
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.
multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation
powder in the treatment of persistent asthma in adults and adolescents.
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to
compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily
and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will
participate in the study for up to a maximum of 29 weeks (including screening, treatment and
follow-up contact). The primary endpoint consists of change from baseline in clinic visit
trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The
nominated powered secondary endpoint is the change from baseline in the percentage of
rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include
adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion.
For subjects who have consented for pharmacogenetics, a blood sample will also be taken for
pharmacogenetic analysis.
compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily
and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will
participate in the study for up to a maximum of 29 weeks (including screening, treatment and
follow-up contact). The primary endpoint consists of change from baseline in clinic visit
trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The
nominated powered secondary endpoint is the change from baseline in the percentage of
rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include
adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion.
For subjects who have consented for pharmacogenetics, a blood sample will also be taken for
pharmacogenetic analysis.
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
We found this trial at
49
sites
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