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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722267
First Posted: July 25, 2008
Last Update Posted: July 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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.

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 ]

Secondary Outcome Measures:
  • Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality. [ Time Frame: Once ]
  • Describe how patient use their COPD treatment [ Time Frame: Once ]
  • Factors that may influence the patient's perception of symptom variability [ Time Frame: Once ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722267


  Show 606 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

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
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: July 28, 2009
Last Verified: July 2009

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

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