Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Disorders
Intervention: Salmeterol and Fluticasone (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Study design: Time Perspective: Prospective
Primary outcome: The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: November 2007
Last updated: August 20, 2013
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