NCT01169727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

1.7 years

First QC Date

July 23, 2010

Last Update Submit

May 30, 2012

Conditions

Keywords

COPD and CCQ scoreChanges in PEF,overall CCQ score

Outcome Measures

Primary Outcomes (1)

  • Changes in PEF and overall CCQ score

    between the first visit and after 12 (plus or minus 1) weeks

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age41 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care and Specialty care in 20 centers nationwide in Thailand

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Male or non-pregnant female aged \>40 years
  • A clinical diagnosis of COPD with FEV1/ FVC \<0.70 and require combination or modified therapy
  • Smoke \> 10 Pack Year

You may not qualify if:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

SaiMai, Bangkok, Thailand

Location

Research Site

Watana, Bangkok, Thailand

Location

Research Site

Maung, Changwat Chanthaburi, Thailand

Location

Research Site

Maung, Changwat Chiang Rai, Thailand

Location

Research Site

Muang, Changwat Chon Buri, Thailand

Location

Research Site

Muang, Changwat Khon Kaen, Thailand

Location

Research Site

Ongkharak, Changwat Nakhon Nayok, Thailand

Location

Research Site

Maung, Changwat Nonthaburi, Thailand

Location

Research Site

Muang, Changwat Phitsanulok, Thailand

Location

Research Site

Maung, Changwat Rayong, Thailand

Location

Research Site

Hat Yai, Changwat Songkhla, Thailand

Location

Research Site

Song Phi Nong, Changwat Suphan Buri, Thailand

Location

Research Site

Maung, Changwat Trang, Thailand

Location

Research Site

Maung, Chiang Mai, Thailand

Location

Research Site

Maung, Nakhon Sri Thammarat, Thailand

Location

Research Site

Maung, Nakhonratchasima, Thailand

Location

Research Site

Maung, Nakhonsawan, Thailand

Location

Research Site

Maung, Phuket, Thailand

Location

Research Site

Maung, Sakolnakorn, Thailand

Location

Research Site

Prannok, Bangkok, Thailand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Assoc. Prof. Watchara Boonsawat

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations