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

A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease and the Limitations of Patients' Activities in Primary Care.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01219946
Acronym
COPD Language
Enrollment
700
Registered
2010-10-13
Start date
2010-10-31
Completion date
2011-03-31
Last updated
2012-03-21

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, symptoms

Brief summary

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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Words used by the patients and the physicians to express the symptoms of COPD as well as the limitations of patients' daily living activities caused by COPD.End of recruitment (estimated timeframe :2.5 months)

Secondary

MeasureTime frame
AgeEnd of recruitment (estimated timeframe :2.5 months)
GenderEnd of recruitment (estimated timeframe :2.5 months)
Place of residenceEnd of recruitment (estimated timeframe :2.5 months)
Marital statusEnd of recruitment (estimated timeframe :2.5 months)
Native languageEnd of recruitment (estimated timeframe :2.5 months)
Educational levelEnd of recruitment (estimated timeframe :2.5 months)
Co-morbiditiesEnd of recruitment (estimated timeframe :2.5 months)
Years / months since COPD diagnosis and years with COPD symptomsEnd of recruitment (estimated timeframe :2.5 months)
Smoking historyEnd of recruitment (estimated timeframe :2.5 months)
OccupationEnd of recruitment (estimated timeframe :2.5 months)
Current therapyEnd of recruitment (estimated timeframe :2.5 months)
CCQ scoreEnd of recruitment (estimated timeframe :2.5 months)
Compliance with therapyEnd of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptomsEnd of recruitment (estimated timeframe :2.5 months)
Scale for the assessment of the severity of the relevant symptomsEnd of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician when any of the symptoms worsenEnd of recruitment (estimated timeframe :2.5 months)
Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptomsEnd of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient regarding chronic daily symptomsEnd of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient when the symptoms worsen.End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last yearEnd of recruitment (estimated timeframe :2.5 months)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026