Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

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.

Completed

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Key information

Conditions

Respiratory Disorders Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salmeterol and Fluticasone

Drug

Primary outcomes

The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Jul 18, 2011
Registry last updated: Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed