Clinical trial NCT01627743: CorRELation Between PatIent PErception and Findings on Clinical Examination
Official title: CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: CDLM
visual scale - physician evaluation
COPD
GOLD group C and D
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 505
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients, group C and D according to GOLD guidelines 2011, being treated for at least 1 month with combination ICS/LABA treatment

Brief 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.

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

Eligibility criteria: 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 β2-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

Primary outcomes:
measure: Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire
timeFrame: Baseline and 3 months
measure: Change from baseline of patient's general health status based upon physician evaluation - visual scale
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Demographic patient characteristics
timeFrame: Day 0 (visit1)
measure: Patient adherence to treatment - visual scale
timeFrame: up to 3 months
measure: Number of daily walking steps (using pedometer)
timeFrame: up to 3 months
measure: Number of exacerbations
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Bacau
country: Romania
facility: Research Site
city: Botosani
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Buzau
country: Romania
facility: Research Site
city: Calarasi
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Drobeta Turnu Severin
country: Romania
facility: Research Site
city: Falticeni
country: Romania
facility: Research Site
city: Focsani
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Leordeni
country: Romania
facility: Research Site
city: Ludus
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Ramnicu Valcea
country: Romania
facility: Research Site
city: Reghin
country: Romania
facility: Research Site
city: Slatina
country: Romania
facility: Research Site
Study officials:
affiliation: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
name: Florin Mihaltan, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References: