Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

GlaxoSmithKline1,001 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,001

Conditions

Respiratory Disorders

Interventions

Salmeterol and FluticasoneDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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