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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01703416
First received: October 3, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition
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

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703416

Locations
Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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:
COPD
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

ClinicalTrials.gov processed this record on July 20, 2014