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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01219946
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Age	End of recruitment (estimated timeframe :2.5 months)
Gender	End of recruitment (estimated timeframe :2.5 months)
Place of residence	End of recruitment (estimated timeframe :2.5 months)
Marital status	End of recruitment (estimated timeframe :2.5 months)
Native language	End of recruitment (estimated timeframe :2.5 months)
Educational level	End of recruitment (estimated timeframe :2.5 months)
Occupation	End of recruitment (estimated timeframe :2.5 months)
Co-morbidities	End of recruitment (estimated timeframe :2.5 months)
Years / months since COPD diagnosis and years with COPD symptoms	End of recruitment (estimated timeframe :2.5 months)
Smoking history	End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last year	End of recruitment (estimated timeframe :2.5 months)
Current therapy	End of recruitment (estimated timeframe :2.5 months)
CCQ score	End of recruitment (estimated timeframe :2.5 months)
Compliance with therapy	End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms	End of recruitment (estimated timeframe :2.5 months)
Scale for the assessment of the severity of the relevant symptoms	End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician when any of the symptoms worsen	End of recruitment (estimated timeframe :2.5 months)
Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms	End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient regarding chronic daily symptoms	End 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)

Trial Locations

Locations (1)

Research Site; 🇬🇷 Xanthi, Traki, Greece