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

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425760
• Other study ID #: D2287R00105
• Status: Completed
• Start date: December 7, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3254
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 Year
Primary	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.	1 Year
Secondary	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	1 Year

External Links

•   CSR Synopsis