Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Completed

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

• Registration Number: NCT01395849
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this post-marketing surveillance is to detect adverse drug reactions (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 treated with fluticasone propionate and salmeterol xinafoate.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-09
• Study Completion: 2011-03
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2116

Inclusion Criteria

• Must use fluticasone and salmeterol for the first time

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 during study period

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events in Japanese asthma patients treated with fluticasone propionate and salmeterol xinafoate	6 months