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NCT01395862 Clinical Trial

Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Respiratory Disorders Clinical Trial

Official title:
Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01395862
Other study ID # 112278
Secondary ID
Status Completed
Phase N/A
First received July 14, 2011
Last updated August 20, 2013
Start date November 2007
Est. completion date September 2012

Study information
Verified date August 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1001
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Salmeterol and Fluticasone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term 1 year Yes
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