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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-07

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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D2287R00105

Identifier Type: -

Identifier Source: org_study_id