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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703416
First Posted: October 10, 2012
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]
  • Change from baseline of patient's general health status upon physical evaluation - visual scale [ Time Frame: Baseline and 3 months ]

Secondary Outcome Measures:
  • Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural) [ Time Frame: Day 0 (visit 1) ]
    Descriptive statistics will be calculated for this outcome measure

  • Number of daily walking steps (by using pedometers) [ Time Frame: up to 3 months ]
  • Patient adherence to treatment (by using visual 5 point scale) [ Time Frame: up to 3 months ]
  • Number of unscheduled visit (exacerbations, emergency visits) [ Time Frame: up to 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703416


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01703416     History of Changes
Other Study ID Numbers: NIS-RBG-ATC-2012/1
First Submitted: October 3, 2012
First Posted: October 10, 2012
Last Update Posted: April 25, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases