Chronic Obstructive Pulmonary DiseaseCOPVARNCT03425760
A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
Trial summary
This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities. It will also explore the current practice in management of stable GOLD C and D COPD patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 3,254 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2015to 31 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stable GOLD C or D COPD patient under maintenance treatment, over 45 years
Who may be able to join
- Patients eligible for inclusion have to fulfill all of the following criteria:
- Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
- COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC < 0.7 and an FEV1 < 50% predicted.
Who cannot join
- Patients are not eligible for inclusion if they meet one of the following criteria:
- Patient with an ongoing COPD exacerbation*;
- Patient who has experienced an exacerbation* in the previous 3 months;
- History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
- Inability to understand the study related questions;
- Mentally disabled patient or unable to read and write;
- Pregnant.
- Current participation in a clinical trial;
About this study
This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.
It will also explore the current practice in management of stable GOLD C and D COPD patients.
Read the detailed description
- Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
- Secondary objectives:
- To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
- To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
- To identify demographic, behavioral and clinical factors associated with symptoms variability.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
Mean score of Morning Activities and Symptoms Questionnaires (MASQ). MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms. The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire. Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions. Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).
Measured: 1 Year
Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT). CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status. There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome.
Measured: 1 Year
Secondary outcomes (1)
Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines
Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start7 Dec 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425760
- Sponsor's protocol ID
- D2287R00105
- Acronym
- COPVAR
- Status last verified
- Jun 2018
- First submitted
- 22 Jan 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
- ClinicalTrials.gov ID
- NCT03425760
- Acronym / sponsor ID
- COPVAR / D2287R00105
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,254 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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 non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.
It will also explore the current practice in management of stable GOLD C and D COPD patients.
Detailed description
- Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
- Secondary objectives:
- To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
- To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
- To identify demographic, behavioral and clinical factors associated with symptoms variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stable GOLD C or D COPD patient under maintenance treatment, over 45 years
Key inclusion criteria (3 listed)
- Patients eligible for inclusion have to fulfill all of the following criteria:
Key exclusion criteria (8 listed)
- Patient with an ongoing COPD exacerbation*;
- Patient who has experienced an exacerbation* in the previous 3 months;
- History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
- Inability to understand the study related questions;
- Mentally disabled patient or unable to read and write;
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
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
Time frame: 1 Year
Mean score of Morning Activities and Symptoms Questionnaires (MASQ). MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms. The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire. Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions. Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).
Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
Time frame: 1 Year
Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT). CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status. There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome.
1 secondary outcome
Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines
Time frame: 1 Year
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 29 Jun 2018.
- CSR SynopsisLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
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 8 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients (time frame: 1 Year). 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 29 Jun 2018.