Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01169727
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive Pulmonary Disease (COPD) patients in response to treatments in clinical practice.

Detailed Description

MC MD

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Male or non-pregnant female aged >40 years
3. A clinical diagnosis of COPD with FEV1/ FVC <0.70 and require combination or modified therapy
4. Smoke > 10 Pack Year

Exclusion Criteria

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in PEF and overall CCQ score	between the first visit and after 12 (plus or minus 1) weeks

Secondary Outcome Measures

Name	Time	Method
Difference of the changes of PEF and overall CCQ score comparing between various treatments	between the first visit and after 12 (plus or minus 1) weeks

Trial Locations

Locations (1)

Research Site; 🇹🇭 Prannok, Bangkok, Thailand