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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01703416

Acronym

RELIEF

Enrollment

500

Registered

2012-10-10

Start date

2012-10-31

Completion date

2013-04-30

Last updated

2013-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, GOLD group C and D, CDLM questionnaire, visual scale - physician evaluation

Brief 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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.	Baseline and 3 months
Change from baseline of patient's general health status upon physical evaluation - visual scale	Baseline and 3 months

Secondary

Measure	Time frame	Description
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)	Day 0 (visit 1)	Descriptive statistics will be calculated for this outcome measure
Number of daily walking steps (by using pedometers)	up to 3 months	—
Patient adherence to treatment (by using visual 5 point scale)	up to 3 months	—
Number of unscheduled visit (exacerbations, emergency visits)	up to 3 months	—

Countries

Bulgaria

Outcome results