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.

• Status: Completed
• Trial end date: 2015-06-23
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Parexel
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.