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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Research Site Baden
Austria Research Site Feldbach
Austria Research Site Feldkirch
Austria Research Site Gussing
Austria Research Site Innsbruck
Austria Research Site Landeck
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Austria Research Site Linz-Urfahr
Austria Research Site Neusiedl am See
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Austria Research Site SchluSSlberg
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Austria Research Site Wels
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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

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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