European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT00722267
• Lead Sponsor: AstraZeneca

Brief Summary

This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7400

Inclusion Criteria

• Outpatients with a diagnosis of COPD
• FEV1<50% and FEV1/FVC<0.7 according to lung function data in medical records.
• Smoker or ex-smoker > 10 pack-years
• Informed consent obtained

Exclusion Criteria

• Ongoing exacerbation of COPD or within the previous 3 months
• Any other significant respiratory disease (including asthma and allergic rhinitis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year	Once

Secondary Outcome Measures

Name	Time	Method
Factors that may influence the patient's perception of symptom variability	Once
Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality.	Once
Describe how patient use their COPD treatment	Once

Trial Locations

Locations (1)

Research Site; 🇬🇧 Westbury, United Kingdom