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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703416
• Other study ID #: NIS-RBG-ATC-2012/1
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: April 24, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.		Baseline and 3 months	No
Primary	Change from baseline of patient's general health status upon physical evaluation - visual scale		Baseline and 3 months	No
Secondary	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)	No
Secondary	Number of daily walking steps (by using pedometers)		up to 3 months	No
Secondary	Patient adherence to treatment (by using visual 5 point scale)		up to 3 months	No
Secondary	Number of unscheduled visit (exacerbations, emergency visits)		up to 3 months	No