Clinical trial NCT01169727: Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
Official title: Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD and CCQ score
Changes in PEF,overall CCQ score
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 684
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care and Specialty care in 20 centers nationwide in Thailand

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in PEF and overall CCQ score
timeFrame: between the first visit and after 12 (plus or minus 1) weeks
Secondary outcomes:
measure: Difference of the changes of PEF and overall CCQ score comparing between various treatments
timeFrame: between the first visit and after 12 (plus or minus 1) weeks
Other outcomes:
Locations:
city: SaiMai
country: Thailand
facility: Research Site
state: Bangkok
city: Watana
country: Thailand
facility: Research Site
state: Bangkok
city: Maung
country: Thailand
facility: Research Site
state: Chantaburi
city: Maung
country: Thailand
facility: Research Site
state: Chiang Mai
city: Maung
country: Thailand
facility: Research Site
state: Chiang Rai
city: Muang
country: Thailand
facility: Research Site
state: Chonburi
city: Muang
country: Thailand
facility: Research Site
state: Khon Kaen
city: Ongkharak
country: Thailand
facility: Research Site
state: Nakhon Nayok
city: Maung
country: Thailand
facility: Research Site
state: Nakhon Sri Thammarat
city: Maung
country: Thailand
facility: Research Site
state: Nakhonratchasima
city: Maung
country: Thailand
facility: Research Site
state: Nakhonsawan
city: Maung
country: Thailand
facility: Research Site
state: Nonthaburi
city: Muang
country: Thailand
facility: Research Site
state: Phitsanulok
city: Maung
country: Thailand
facility: Research Site
state: Phuket
city: Maung
country: Thailand
facility: Research Site
state: Rayong
city: Maung
country: Thailand
facility: Research Site
state: Sakolnakorn
city: Hat Yai
country: Thailand
facility: Research Site
state: Songkla
city: Song Phi Nong
country: Thailand
facility: Research Site
state: Suphan Buri
city: Maung
country: Thailand
facility: Research Site
state: Trang
city: Prannok, Bangkok
country: Thailand
facility: Research Site
Study officials:
affiliation: Khon Kaen University
name: Assoc. Prof. Watchara Boonsawat
role: PRINCIPAL_INVESTIGATOR
References: