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NCT Number: NCT01703416

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sofia, Bulgaria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.

    Time frame: Baseline and 3 months

  2. Change from baseline of patient's general health status upon physical evaluation - visual scale

    Time frame: Baseline and 3 months

Secondary outcomes

  1. 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

  2. Number of daily walking steps (by using pedometers)

    Time frame: up to 3 months

  3. Patient adherence to treatment (by using visual 5 point scale)

    Time frame: up to 3 months

  4. Number of unscheduled visit (exacerbations, emergency visits)

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RELIEF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 10, 2012
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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