A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01219946

Last Updated: 2012-03-21

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

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration.

Even though subjective in nature, the symptomatology of COPD and mainly that of breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking into consideration that the symptoms experienced by the patient who suffers from a progressive disease such as COPD can only be perceived and interpreted by the patient him- or herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.

Therefore, there is a need to carry out qualitative studies that will provide insight into the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a further mapping of the impact that COPD symptoms' perception has on a patient's life is required, as well as of the different pathways through which symptoms' perception is interpreted regarding the limitations of daily living activities, and the subsequent impact on disease management. The more the physician learns on the embodied experience of COPD, the better he/she may assist the patient in achieving optimal COPD management.

Thus this cross-sectional observational study was designed aiming to obtain these data. Specifically, the study aims to evaluate the most frequently used words by the patients and the physicians to express the symptoms of COPD as well as the limitation of activities that it causes.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Patients with Chronic Obstructive Pulmonary Disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 45-75 years
* Current or former smokers
* Known history of COPD for at least 6 months before enrolment into the study documented by spirometry (FEV1 /FVC \<70%)
* Patients with stable COPD (no exacerbation within the last month before enrolment into the study) under treatment with a long-acting inhaled bronchodilator (LABA and/or LAMA) alone or in combination with an inhaled corticosteroid
* Written consent for participation in the study
* Patients who are able to complete by themselves in Greek a questionnaire on COPD.

Exclusion Criteria

* Patients with diagnosed Asthma
* Patients with any psychiatric, neurological or other disorder render them unable to complete the COPD questionnaire by themselves
* The patient participates in another study.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 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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Panagiotis Pontikis

Role: STUDY_DIRECTOR

Locations

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Research Site

Athens, Attica, Greece

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Kallithea, Attica, Greece

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Marousi, Attica, Greece

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Megara, Attica, Greece

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Nea Ionia, Attica, Greece

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Nea Makri, Attica, Greece

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Piraeus, Attica, Greece

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Chania, Crete, Greece

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Heraklion, Crete, Greece

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Rhodes, Dodekanisa, Greece

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Corfu, Eptanisa, Greece

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Ioannina, Ipiros, Greece

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Larissa, Kyklades, Greece

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Mykonos, Kyklades, Greece

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Alexándreia, Makedonia, Greece

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Drama, Makedonia, Greece

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Florina, Makedonia, Greece

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Katerini, Makedonia, Greece

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Kavala, Makedonia, Greece

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Kozani, Makedonia, Greece

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Serres, Makedonia, Greece

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Thesaloniki, Makedonia, Greece

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Krestena, Peloponisos, Greece

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Lechainá, Peloponisos, Greece

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Pátrai, Peloponisos, Greece

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Skála, Peloponisos, Greece

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Agrinio, Sterea, Greece

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Halkida, Sterea, Greece

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Itea, Sterea, Greece

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Livadia, Sterea, Greece

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Volos, Thesalia, Greece

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Xánthi, Traki, Greece

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Countries

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Greece

Other Identifiers

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NIS-RGR-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id

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