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Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

NCT ID: NCT01395862

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1001 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Respiratory Disorders

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed fluticasone and salmeterol

Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period

Salmeterol and Fluticasone

Intervention Type DRUG

Interventions

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Salmeterol and Fluticasone

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112278

Identifier Type: -

Identifier Source: org_study_id