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.
Condition: Asthma
MeSH terms: Asthma
Intervention: ADVAIR 100/50mcg; ADVAIR 250/50mcg; ADVAIR 500/50mcg; FLOVENT 100mcg; FLOVENT 250mcg; FLOVENT 500mcg
Intervention description: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate (100) twice daily (AM and PM) for 6 months; fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months; fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11751.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: ADVAIR; Asthma; safety; FLOVENT

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.
    

Eligibility 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.