Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.

Detailed Description
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CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study

Official Title
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CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011 Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study Current or past smokers, of at least 10 pack years Exclusion Criteria: History of exacerbation of COPD symptoms within the last month before visit 1, inclusive. History of asthma or allergic rhinitis. History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire. |  | Baseline and 3 months | 
| Change from baseline of patient's general health status upon physical evaluation - visual scale |  | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural) | Descriptive statistics will be calculated for this outcome measure | Day 0 (visit 1) | 
| Number of daily walking steps (by using pedometers) |  | up to 3 months | 
| Patient adherence to treatment (by using visual 5 point scale) |  | up to 3 months | 
| Number of unscheduled visit (exacerbations, emergency visits) |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, GOLD group C and D, CDLM questionnaire, visual scale - physician evaluation