Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Completed

• Conditions: Respiratory Disorders
• Interventions: Drug: Salmeterol and Fluticasone

• Registration Number: NCT01395862
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1001

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed fluticasone and salmeterol	Salmeterol and Fluticasone	Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term	1 year