COPDSYMBOLNCT00894426
Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
An observational study of COPD, run by AstraZeneca at 3 sites in South Korea.
Trial summary
The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD
- How many people
- 150 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2009to Dec 2009
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The inclusion/exclusion criteria are designed to select subjects suffering from severe COPD (according to spirometric classification, GOLD stage III and IV) and in a stable state
Who may be able to join
- COPD outpatients over 45 years old
- Lung function: post-FEV1 < 50%
- Current or ex-smoker > 10 packs per year
- Patients who were not on medication of ISC/FC at least 2 weeks
Who cannot join
- Ongoing exacerbation of COPD or within the previous 3 months
- History of asthma or allergic rhinitis
- Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
- Current participation in an interventional clinical trial
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Daegu
Research Site
Gyongiju
Research Site
Pohang
About this study
Official title: Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.
- Conditions
- COPD
- Keywords
- COPD, Symptom, Morning activity, Questionnaire
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Morning Symptoms (+) | |
| 2 | Morning Symptoms (-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the perception of COPD Patients in symptoms related to morning activities
Measured: At baseline and last visit (after 2~3 months)
Secondary outcomes (3)
To assess the patient's perception of the variability of symptoms
Measured: At baseline and last visit (after 2~3 months)
To describe how patients use their COPD treatments
Measured: At baseline and last visit (after 2~3 months)
To investigate factors that may influence the patient's perception of symptom variability (such as patient characteristics, COPD treatments, co morbidities, etc…)
Measured: At baseline and last visit (after 2~3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joonwoo Bahn, Study director, Astrazenca Korea, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894426
- Sponsor's protocol ID
- NIS-RKR-DUM-2009/1
- Acronym
- SYMBOL
- Status last verified
- Dec 2010
- First submitted
- 28 Apr 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT00894426
- Acronym / sponsor ID
- SYMBOL / NIS-RKR-DUM-2009/1
- Conditions
- COPD
- Keywords
- COPD, Symptom, Morning activity, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 7 May 2009 (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 aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Morning Symptoms (+) |
| 2 | – | –Morning Symptoms (-) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion/exclusion criteria are designed to select subjects suffering from severe COPD (according to spirometric classification, GOLD stage III and IV) and in a stable state
Key inclusion criteria (4 listed)
- COPD outpatients over 45 years old
- Lung function: post-FEV1 < 50%
- Current or ex-smoker > 10 packs per year
- Patients who were not on medication of ISC/FC at least 2 weeks
Key exclusion criteria (4 listed)
- Ongoing exacerbation of COPD or within the previous 3 months
- History of asthma or allergic rhinitis
- Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
- Current participation in an interventional clinical trial
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
To assess the perception of COPD Patients in symptoms related to morning activities
Time frame: At baseline and last visit (after 2~3 months)
3 secondary outcomes
To assess the patient's perception of the variability of symptoms
Time frame: At baseline and last visit (after 2~3 months)
To describe how patients use their COPD treatments
Time frame: At baseline and last visit (after 2~3 months)
To investigate factors that may influence the patient's perception of symptom variability (such as patient characteristics, COPD treatments, co morbidities, etc…)
Time frame: At baseline and last visit (after 2~3 months)
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 3 Dec 2010.
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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.
Joonwoo Bahn study director
Astrazenca Korea, Medical Department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by AstraZeneca at 3 sites in South Korea.
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 4 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 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
To assess the perception of COPD Patients in symptoms related to morning activities (time frame: At baseline and last visit (after 2~3 months)). 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 3 Dec 2010.