CorRELation Between PatIent PErception and Findings on Clinical Examination

NCT ID: NCT01627743

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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

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

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients grade C and D

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florin Mihaltan, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy Carol Davila, Bucharest, Romania

Locations

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Research Site

Bacau, , Romania

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Botoșani, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Călăraşi, , Romania

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Cluj-Napoca, , Romania

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Constanța, , Romania

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Craiova, , Romania

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Drobeta-Turnu Severin, , Romania

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Fălticeni, , Romania

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Focşani, , Romania

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Iași, , Romania

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Leordeni, , Romania

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Luduş, , Romania

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Oradea, , Romania

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Ploieşti, , Romania

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Râmnicu Vâlcea, , Romania

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Reghin, , Romania

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Slatina, , Romania

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Countries

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Romania

Other Identifiers

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NIS-RRO-ATC-2012/1

Identifier Type: -

Identifier Source: org_study_id

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