SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
Completed · Phase 4
Conditions studied: Asthma
In brief
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
Key facts
- Study ID
- NCT01475721
- Run by
- GlaxoSmithKline
- People needed
- 11751
- Starts
- 2011-11-18
- Expected to finish
- 2015-06-23
- Last updated by the study team
- 2018-08-06
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provided consent to participate in the study
- Male or female, 12 years of age and older
- Clinical diagnosis of asthma for at least 1 year prior to the randomization
- Clinic PEF of greater than or equal to 50% of predicted normal value
- Subject must be appropriately using one of the treatments for asthma listed in the protocol
- Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
- Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization
You may not qualify if…
- History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
- Concurrent respiratory disease other than asthma
- Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
- Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
- Presence of a bacterial or viral respiratory infection that is not resolved at randomization
- An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
- More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- Subject must not meet unstable asthma severity criteria as listed in the protocol
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
- Pregnancy, breast-feeding or planned pregnancy during the study
- A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Where it is running
- GSK Investigational Site — Birmingham, Alabama, United States
- GSK Investigational Site — Birmingham, Alabama, United States
- GSK Investigational Site — Birmingham, Alabama, United States
- GSK Investigational Site — Florence, Alabama, United States
- GSK Investigational Site — Mobile, Alabama, United States
- GSK Investigational Site — Montgomery, Alabama, United States
- GSK Investigational Site — Pell City, Alabama, United States
- GSK Investigational Site — Scottsboro, Alabama, United States
- GSK Investigational Site — Toney, Alabama, United States
- GSK Investigational Site — Tuscaloosa, Alabama, United States
- GSK Investigational Site — Chandler, Arizona, United States
- GSK Investigational Site — Flagstaff, Arizona, United States
- GSK Investigational Site — Goodyear, Arizona, United States
- GSK Investigational Site — Green Valley, Arizona, United States
- GSK Investigational Site — Mesa, Arizona, United States
- GSK Investigational Site — Mesa, Arizona, United States
- GSK Investigational Site — Peoria, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Scottsdale, Arizona, United States
- GSK Investigational Site — Sierra Vista, Arizona, United States
- GSK Investigational Site — Tucson, Arizona, United States
- GSK Investigational Site — Athens, Alabama, United States
Full record on ClinicalTrials.gov
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