CorRELation Between PatIent PErception and Findings on Clinical Examination

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— RELIEF  

Official title:

CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627743
• Other study ID #: NIS-RRO-ATC-2012/1
• Status: Completed
• Phase: N/A
• First received: June 22, 2012
• Last updated: February 20, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeRomania: National Agency for Medicines and Medical Devices
• Study type: Observational

Clinical Trial Summary

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice, the possible corelation between patIent perception of the ability to perform morning activities and physician evaluation; patients with COPD, grade C and D.

Description:

CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD, grade C and D according to GOLD Guidelines Revised 2011

• Current or past smokers, of at least 10 pack years

• Receive any inhaled combination therapy for COPD (inhaled corticosteroid / long acting ß2-agonist bronchodilator) initiated for at least one month before entering in the study

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

• Inability to understand study procedures and inability/refuse to complete CDLM questionnaires and/or record the values showed on the pedometer screen

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Romania	Research Site	Bacau
Romania	Research Site	Botosani
Romania	Research Site	Bucuresti
Romania	Research Site	Buzau
Romania	Research Site	Calarasi
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Constanta
Romania	Research Site	Craiova
Romania	Research Site	Drobeta Turnu Severin
Romania	Research Site	Falticeni
Romania	Research Site	Focsani
Romania	Research Site	Iasi
Romania	Research Site	Leordeni
Romania	Research Site	Ludus
Romania	Research Site	Oradea
Romania	Research Site	Ploiesti
Romania	Research Site	Ramnicu Valcea
Romania	Research Site	Reghin
Romania	Research Site	Slatina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire	CDLM questionnaire is a simple self-reporting tool of the burden and ability of COPD patients to perform routine morning activities: washing, dressing, eating breakfast, walking around. For each of these morning activities the score is varying from 0 (indicating worst case) to 5 (indicating best case).	Baseline and 3 months	No
Primary	Change from baseline of patient's general health status based upon physician evaluation - visual scale	General health status visual scale is assessing the physicians perception of the patient health status following the clinical examination. Based upon clinical evaluation, the physician will indicate the patient's general condition on a a scale consisting of 5 levels. The scale will be completed at each visit and the score can vary from 1(very bad general health status) to 5 (very good general health status) .	Baseline and 3 months	No
Secondary	Demographic patient characteristics	Demographic patient characteristics are: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban, rural)	Day 0 (visit1)	No
Secondary	Patient adherence to treatment - visual scale	The physician will evaluate adherence to treatment, after discussion with patient, by completing a visual scale for evaluation patient's adherence to treatment (adherence will be assessed in percentage, by indicating at the scale the value from 0% to 100% adherence).; The visual scale has the following cut-off points: 0% (no adherence to treatment), 25% (poor adherence), 50% (medium adherence), 75% (good adherence), 100% (high adherence).	up to 3 months	No
Secondary	Number of daily walking steps (using pedometer)	The pedometers register the total daily walking steps. Each morning, the subject will reset the device by pressing the on/reset button. At the end of the day, the patient will record the number of daily walking steps. The estimated value for number of walking steps is 2,500 - 4,500 steps/day (based on previous studies).	up to 3 months	No
Secondary	Number of exacerbations	Exacerbation is defined as a worsening of COPD symptoms that is beyond day-to-day variations and that requires antibiotic treatment and/or short systemic corticoid treatment and/or emergency room visit with or without hospital admission (according to GOLD criteria and previous studies).	up to 3 months	No