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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01703416
• Lead Sponsor: AstraZeneca

Brief Summary

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

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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-10
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)	Day 0 (visit 1)	Descriptive statistics will be calculated for this outcome measure
Number of daily walking steps (by using pedometers)	up to 3 months