Chronic Obstructive Pulmonary DiseaseNCT01169727
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 684 participants
- Where
- 20 sitesThailand
- Study dates
- Jul 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care and Specialty care in 20 centers nationwide in Thailand
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Thailand20 sites
Research Site
Hat Yai, Changwat Songkhla
Research Site
Maung, Changwat Chanthaburi
Research Site
Maung, Changwat Chiang Rai
Research Site
Maung, Changwat Nonthaburi
Research Site
Maung, Changwat Rayong
Research Site
Maung, Changwat Trang
Research Site
Maung, Chiang Mai
Research Site
Maung, Nakhon Sri Thammarat
Research Site
Maung, Nakhonratchasima
Research Site
Maung, Nakhonsawan
Research Site
Maung, Phuket
Research Site
Maung, Sakolnakorn
Research Site
Muang, Changwat Chon Buri
Research Site
Muang, Changwat Khon Kaen
Research Site
Muang, Changwat Phitsanulok
Research Site
Ongkharak, Changwat Nakhon Nayok
Research Site
Prannok, Bangkok
Research Site
SaiMai, Bangkok
Research Site
Song Phi Nong, Changwat Suphan Buri
Research Site
Watana, Bangkok
About this study
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.
Read the detailed description
MC MD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD and CCQ score, Changes in PEF,overall CCQ score
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PEF and overall CCQ score
Measured: 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
Measured: between the first visit and after 12 (plus or minus 1) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Assoc. Prof. Watchara Boonsawat, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169727
- Sponsor's protocol ID
- NIS-RTH-DUM-2009/2
- Status last verified
- May 2012
- First submitted
- 23 Jul 2010
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
- ClinicalTrials.gov ID
- NCT01169727
- Acronym / sponsor ID
- NIS-RTH-DUM-2009/2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD and CCQ score, Changes in PEF,overall CCQ score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care and Specialty care in 20 centers nationwide in Thailand
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in PEF and overall CCQ score
Time frame: between the first visit and after 12 (plus or minus 1) weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assoc. Prof. Watchara Boonsawat principal investigator
Khon Kaen University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PEF and overall CCQ score (time frame: between the first visit and after 12 (plus or minus 1) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.