Status:
COMPLETED
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.
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Parexel
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is comp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2015
Estimated Enrollment :
11751 Patients enrolled
Trial Details
Trial ID
NCT01475721
Start Date
November 18 2011
End Date
June 23 2015
Last Update
August 6 2018
Active Locations (808)
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1
GSK Investigational Site
Athens, Alabama, United States, 35611
2
GSK Investigational Site
Birmingham, Alabama, United States, 35209
3
GSK Investigational Site
Birmingham, Alabama, United States, 35216
4
GSK Investigational Site
Birmingham, Alabama, United States, 35233