Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients
RELIEF
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
1 other identifier
observational
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 25, 2013
April 1, 2013
6 months
October 3, 2012
April 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)
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
Study Arms (1)
1
Eligibility Criteria
Chronic Obstructive Pulmonary Disease (COPD) patients group C and D
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 10, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 25, 2013
Record last verified: 2013-04