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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|---|---|---|---|
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| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Blackburn | |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Bradford-On-Avon | |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Chertsey | |
| United Kingdom | Research Site | Chesterfield | |
| United Kingdom | Research Site | Chippenham | |
| United Kingdom | Research Site | Cookstown | |
| United Kingdom | Research Site | Corsham | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Doncaster | |
| United Kingdom | Research Site | Fife | |
| United Kingdom | Research Site | High Valleyfield | |
| United Kingdom | Research Site | Maidenhead | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Plymouth | |
| United Kingdom | Research Site | Ruislip | |
| United Kingdom | Research Site | Sandy | |
| United Kingdom | Research Site | Southampton | |
| United Kingdom | Research Site | Sunbury on Thames | |
| United Kingdom | Research Site | Thornton Heath | |
| United Kingdom | Research Site | Trowbridge | |
| United Kingdom | Research Site | Warminster | |
| 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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