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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 23, 2008
Last updated: July 24, 2009
Last verified: July 2009
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

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

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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00722267

  Show 606 Study Locations
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rick Lones, MD, European Medical Affairs Director, AstraZeneca Pharmaceuticals 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

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 processed this record on July 19, 2017