Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.
NCT number | NCT00722267 |
Other study ID # | NIS-REU-DUM-2007/1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2008 |
Est. completion date | February 2009 |
Verified date | July 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 7400 |
Est. completion date | February 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
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) |
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United Kingdom | Research Site | Wells next the Sea | |
United Kingdom | Research Site | Westbury |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year | Once | ||
Secondary | Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality. | Once | ||
Secondary | Describe how patient use their COPD treatment | Once | ||
Secondary | Factors that may influence the patient's perception of symptom variability | Once |
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