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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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01169727
First received: July 23, 2010
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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:

MC MD

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care and Specialty care in 20 centers nationwide in Thailand

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169727

Locations
Thailand
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
AstraZeneca
Investigators
Principal Investigator: Assoc. Prof. Watchara Boonsawat Khon Kaen University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
Thailand: Ministry of Public Health

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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013