Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 2/16/2018 |
| Start Date: | August 20, 2010 |
| End Date: | October 19, 2011 |
HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents
The purpose of the study is to compare the efficacy and safety of fluticasone
furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder
both administered once daily in adolescent and adult subjects 12 years of age and older with
persistent bronchial asthma over a 12 week treatment period.
furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder
both administered once daily in adolescent and adult subjects 12 years of age and older with
persistent bronchial asthma over a 12 week treatment period.
Inclusion Criteria:
- Outpatients at least 12 years of age
- Male and female; female subjects of childbearing potential must be willing to use
birth control
- Pre-bronchodilator FEV1 of 40-90% predicted normal
- Reversibility FEV1 of at least 12% and 200mL
- Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior
to first visit
Exclusion Criteria:
- History of life-threatening asthma during last 10 years
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that required overnight
hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies to study drugs or the excipients
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with a smoking history of at least 10 pack years
We found this trial at
23
sites
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