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

May 30, 2012 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Detailed Description

MC MD

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Prannok, Bangkok, Thailand
        • Research Site
    • Bangkok
      • SaiMai, Bangkok, Thailand
        • Research Site
      • Watana, Bangkok, Thailand
        • Research Site
    • Chantaburi
      • Maung, Chantaburi, Thailand
        • Research Site
    • Chiang Mai
      • Maung, Chiang Mai, Thailand
        • Research Site
    • Chiang Rai
      • Maung, Chiang Rai, Thailand
        • Research Site
    • Chonburi
      • Muang, Chonburi, Thailand
        • Research Site
    • Khon Kaen
      • Muang, Khon Kaen, Thailand
        • Research Site
    • Nakhon Nayok
      • Ongkharak, Nakhon Nayok, Thailand
        • Research Site
    • Nakhon Sri Thammarat
      • Maung, Nakhon Sri Thammarat, Thailand
        • Research Site
    • Nakhonratchasima
      • Maung, Nakhonratchasima, Thailand
        • Research Site
    • Nakhonsawan
      • Maung, Nakhonsawan, Thailand
        • Research Site
    • Nonthaburi
      • Maung, Nonthaburi, Thailand
        • Research Site
    • Phitsanulok
      • Muang, Phitsanulok, Thailand
        • Research Site
    • Phuket
      • Maung, Phuket, Thailand
        • Research Site
    • Rayong
      • Maung, Rayong, Thailand
        • Research Site
    • Sakolnakorn
      • Maung, Sakolnakorn, Thailand
        • Research Site
    • Songkla
      • Hat Yai, Songkla, Thailand
        • Research Site
    • Suphan Buri
      • Song Phi Nong, Suphan Buri, Thailand
        • Research Site
    • Trang
      • Maung, Trang, Thailand
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care and Specialty care in 20 centers nationwide in Thailand

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
between the first visit and after 12 (plus or minus 1) weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Assoc. Prof. Watchara Boonsawat, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RTH-DUM-2009/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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