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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00722267
First received: July 23, 2008
Last updated: July 24, 2009
Last verified: July 2009
History of Changes
  Purpose

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


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year [ Time Frame: Once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality. [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Describe how patient use their COPD treatment [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Factors that may influence the patient's perception of symptom variability [ Time Frame: Once ] [ Designated as safety issue: No ]

Estimated Enrollment: 7400
Study Start Date: July 2008
Study Completion Date: February 2009
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participating physicians (GPs and Respiratory physicians) will be asked to recruit 4 patients (on average). The first patients presenting for a consultation for any reason, who meet eligibility criteria, and give informed consent, should be enrolled.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722267

  Show 606 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rick Lones, MD, European Medical Affairs Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00722267     History of Changes
Other Study ID Numbers: NIS-REU-DUM-2007/1
Study First Received: July 23, 2008
Last Updated: July 24, 2009
Health Authority: Belgium: Institutional Review Board
Denmark: Ethics Committee
Finland: Ethics Committee
France: French Data Protection Authority
Germany: Ethics Commission
Greece: Ethics Committee
Greece: National Organization of Medicines
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Norway:National Committee for Medical and Health Research Ethics
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
severe COPD
COPD symptoms
variability of symptoms
patient's perception

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013