Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01395862
Collaborator
(none)
1,001
58
Study Details
Study Description
Brief Summary
The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1001 participants
Time Perspective:
Prospective
Official Title:
Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Study Start Date
:
Nov 1, 2007
Actual Primary Completion Date
:
Sep 1, 2012
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients prescribed fluticasone and salmeterol Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period |
Drug: Salmeterol and Fluticasone
|
Outcome Measures
Primary Outcome Measures
- The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Must use fluticasone and salmeterol for the first time
-
Must use fluticasone and salmeterol for long-term
Exclusion Criteria:
-
Patients with hypersensitivity to salmeterol and fluticasone
-
Patients with infection which salmeterol and fluticasone is not effective
-
Patients with deep mycosis
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395862
Other Study ID Numbers:
- 112278
First Posted:
Jul 18, 2011
Last Update Posted:
Aug 21, 2013
Last Verified:
Aug 1, 2013
Additional relevant MeSH terms: