Chronic Obstructive Pulmonary Disease (COPD)RELIEFNCT01703416
Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 2 sites in Bulgaria.
Trial summary
This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 500 participants
- Where
- 2 sitesBulgaria
- Study dates
- Oct 2012to Apr 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Obstructive Pulmonary Disease (COPD) patients group C and D
Who may be able to join
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
- Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
- Current or past smokers, of at least 10 pack years
Who cannot join
- History of exacerbation of COPD symptoms within the last month before visit 1, inclusive.
- History of asthma or allergic rhinitis.
- History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study
This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.
Read the detailed description
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study
- Keywords
- COPD, GOLD group C and D, CDLM questionnaire, visual scale - physician evaluation
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.
Measured: Baseline and 3 months
Change from baseline of patient's general health status upon physical evaluation - visual scale
Measured: Baseline and 3 months
Secondary outcomes (4)
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)
Descriptive statistics will be calculated for this outcome measure
Measured: Day 0 (visit 1)
Number of daily walking steps (by using pedometers)
Measured: up to 3 months
Patient adherence to treatment (by using visual 5 point scale)
Measured: up to 3 months
Number of unscheduled visit (exacerbations, emergency visits)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703416
- Sponsor's protocol ID
- NIS-RBG-ATC-2012/1
- Acronym
- RELIEF
- Status last verified
- Apr 2013
- First submitted
- 3 Oct 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study
- ClinicalTrials.gov ID
- NCT01703416
- Acronym / sponsor ID
- RELIEF / NIS-RBG-ATC-2012/1
- Keywords
- COPD, GOLD group C and D, CDLM questionnaire, visual scale - physician evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Oct 2012 (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.
This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.
Detailed description
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease (COPD) patients group C and D
Key inclusion criteria (3 listed)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
- Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
- Current or past smokers, of at least 10 pack years
Key exclusion criteria (3 listed)
- History of exacerbation of COPD symptoms within the last month before visit 1, inclusive.
- History of asthma or allergic rhinitis.
- History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.
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
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.
Time frame: Baseline and 3 months
Change from baseline of patient's general health status upon physical evaluation - visual scale
Time frame: Baseline and 3 months
4 secondary outcomes
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)
Time frame: Day 0 (visit 1)
Number of daily walking steps (by using pedometers)
Time frame: up to 3 months
Patient adherence to treatment (by using visual 5 point scale)
Time frame: up to 3 months
Number of unscheduled visit (exacerbations, emergency visits)
Time frame: up to 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 25 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 (COPD), run by AstraZeneca at 2 sites in Bulgaria.
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 3 inclusion and 3 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. 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?
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire. (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. 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 25 Apr 2013.