Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
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.
| Status | Completed |
| Enrollment | 684 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 41 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Research Site | Hat Yai | Songkla |
| Thailand | Research Site | Maung | Trang |
| Thailand | Research Site | Maung | Phuket |
| Thailand | Research Site | Maung | Rayong |
| Thailand | Research Site | Maung | Sakolnakorn |
| Thailand | Research Site | Maung | Chantaburi |
| Thailand | Research Site | Maung | Chiang Mai |
| Thailand | Research Site | Maung | Chiang Rai |
| Thailand | Research Site | Maung | Nakhon Sri Thammarat |
| Thailand | Research Site | Maung | Nakhonratchasima |
| Thailand | Research Site | Maung | Nakhonsawan |
| Thailand | Research Site | Maung | Nonthaburi |
| Thailand | Research Site | Muang | Phitsanulok |
| Thailand | Research Site | Muang | Chonburi |
| Thailand | Research Site | Muang | Khon Kaen |
| Thailand | Research Site | Ongkharak | Nakhon Nayok |
| Thailand | Research Site | Prannok, Bangkok | |
| Thailand | Research Site | SaiMai | Bangkok |
| Thailand | Research Site | Song Phi Nong | Suphan Buri |
| Thailand | Research Site | Watana | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in PEF and overall CCQ score | between the first visit and after 12 (plus or minus 1) weeks | No | |
| Secondary | 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 | No |
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