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A Cross-sectional Study of COPD and Symptom Variability in MEA Countries (COPVAR)

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ClinicalTrials.gov Identifier: NCT03425760
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.


Condition or disease
Chronic Obstructive Pulmonary Disease

Detailed Description:
  1. 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
  2. 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 Type : Observational
Actual Enrollment : 3092 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
Actual Study Start Date : December 7, 2015
Primary Completion Date : March 31, 2017
Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  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 [ Time Frame: 1 Year ]
    Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable GOLD C or D COPD patient under maintenance treatment, over 45 years
Criteria

Inclusion Criteria:

  • Patients eligible for inclusion have to fulfill all of the following criteria:

    1. Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
    2. COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC < 0.7 and an FEV1 < 50% predicted.

Exclusion Criteria:

Patients are not eligible for inclusion if they meet one of the following criteria:

  1. Patient with an ongoing COPD exacerbation*;
  2. Patient who has experienced an exacerbation* in the previous 3 months;
  3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
  4. Inability to understand the study related questions;
  5. Mentally disabled patient or unable to read and write;
  6. Pregnant.
  7. Current participation in a clinical trial;

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03425760     History of Changes
Other Study ID Numbers: D2287R00105
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases