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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 23, 2010
Last updated: May 30, 2012
Last verified: May 2012
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.

Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Changes in PEF and overall CCQ score [ Time Frame: between the first visit and after 12 (plus or minus 1) weeks ]

Secondary Outcome Measures:
  • Difference of the changes of PEF and overall CCQ score comparing between various treatments [ Time Frame: between the first visit and after 12 (plus or minus 1) weeks ]

Enrollment: 684
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care and Specialty care in 20 centers nationwide in Thailand

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01169727

Research Site
SaiMai, Bangkok, Thailand
Research Site
Watana, Bangkok, Thailand
Research Site
Maung, Chantaburi, Thailand
Research Site
Maung, Chiang Mai, Thailand
Research Site
Maung, Chiang Rai, Thailand
Research Site
Muang, Chonburi, Thailand
Research Site
Muang, Khon Kaen, Thailand
Research Site
Ongkharak, Nakhon Nayok, 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
Maung, Phuket, Thailand
Research Site
Maung, Rayong, Thailand
Research Site
Maung, Sakolnakorn, Thailand
Research Site
Hat Yai, Songkla, Thailand
Research Site
Song Phi Nong, Suphan Buri, Thailand
Research Site
Maung, Trang, Thailand
Research Site
Prannok, Bangkok, Thailand
Sponsors and Collaborators
Principal Investigator: Assoc. Prof. Watchara Boonsawat Khon Kaen University
  More Information

Responsible Party: AstraZeneca Identifier: NCT01169727     History of Changes
Other Study ID Numbers: NIS-RTH-DUM-2009/2
Study First Received: July 23, 2010
Last Updated: May 30, 2012

Keywords provided by AstraZeneca:
COPD and CCQ score
Changes in PEF,overall CCQ score

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on May 25, 2017