Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01395862

Enrollment

1001

Registered

2011-07-18

Start date

2007-11-30

Completion date

2012-09-30

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disorders

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.

Interventions

DRUGSalmeterol and Fluticasone

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026