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Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease (SYMBOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894426
First Posted: May 7, 2009
Last Update Posted: December 3, 2010
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
The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.

Condition
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the perception of COPD Patients in symptoms related to morning activities [ Time Frame: At baseline and last visit (after 2~3 months) ]

Secondary Outcome Measures:
  • To assess the patient's perception of the variability of symptoms [ Time Frame: At baseline and last visit (after 2~3 months) ]
  • To describe how patients use their COPD treatments [ Time Frame: At baseline and last visit (after 2~3 months) ]
  • To investigate factors that may influence the patient's perception of symptom variability (such as patient characteristics, COPD treatments, co morbidities, etc…) [ Time Frame: At baseline and last visit (after 2~3 months) ]

Estimated Enrollment: 150
Study Start Date: May 2009
Study Completion Date: December 2009
Groups/Cohorts
1
Morning Symptoms (+)
2
Morning Symptoms (-)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The inclusion/exclusion criteria are designed to select subjects suffering from severe COPD (according to spirometric classification, GOLD stage III and IV) and in a stable state
Criteria

Inclusion Criteria:

  • COPD outpatients over 45 years old
  • Lung function: post-FEV1 < 50%
  • Current or ex-smoker > 10 packs per year
  • Patients who were not on medication of ISC/FC at least 2 weeks

Exclusion Criteria:

  • Ongoing exacerbation of COPD or within the previous 3 months
  • History of asthma or allergic rhinitis
  • Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
  • Current participation in an interventional clinical trial
  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): NCT00894426


Locations
Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Gyongiju, Korea, Republic of
Research Site
Pohang, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joonwoo Bahn Astrazenca Korea, Medical Department
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00894426     History of Changes
Other Study ID Numbers: NIS-RKR-DUM-2009/1
First Submitted: April 28, 2009
First Posted: May 7, 2009
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
COPD
Symptom
Morning activity
Questionnaire

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