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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 3, 2012
Last updated: April 24, 2013
Last verified: April 2013

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.

Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change from baseline of patient's general health status upon physical evaluation - visual scale [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural) [ Time Frame: Day 0 (visit 1) ] [ Designated as safety issue: No ]
    Descriptive statistics will be calculated for this outcome measure

  • Number of daily walking steps (by using pedometers) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Patient adherence to treatment (by using visual 5 point scale) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Number of unscheduled visit (exacerbations, emergency visits) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

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


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chronic Obstructive Pulmonary Disease (COPD) patients group C and D


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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01703416

Sofia, Bulgaria
Varna, Bulgaria
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01703416     History of Changes
Other Study ID Numbers: NIS-RBG-ATC-2012/1
Study First Received: October 3, 2012
Last Updated: April 24, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
GOLD group C and D
CDLM questionnaire
visual scale - physician evaluation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases processed this record on April 17, 2014