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
  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:


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 April 15, 2014