Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
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
To investigate possible problems or questions in safety and effectiveness of salmeterol and
fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic /
emphysema). In this special drug use investigation, onset of pneumonia shall be handled as
the priority investigation item.
Clinical Details
Official title: Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
Study design: Time Perspective: Prospective
Primary outcome: The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must use salmeterol and fluticasone for the first time
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
GSK Investigational Site, Chiba 296-8602, Japan
Additional Information
Related publications: Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (AdoairĀ®250DiskusĀ®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.
Starting date: August 2009
Last updated: June 6, 2013
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