Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Salmeterol and Fluticasone

• Registration Number: NCT01332409
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Primary Completion: 2012-04
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed salmeterol and fluticasone	Salmeterol and Fluticasone	Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice.	1 year

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Chiba, Japan