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

NCT03425760 | Completed

• 1 other identifier: D2287R00105
• Study Type: observational
• Target: 3,254
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 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

  1 Year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable GOLD C or D COPD patient under maintenance treatment, over 45 years

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AstraZeneca: lead

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 8, 2018
• Study Start: December 7, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 29, 2018

Record last verified: 2018-06