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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00894426
First received: April 28, 2009
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • To describe how patients use their COPD treatments [ Time Frame: At baseline and last visit (after 2~3 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00894426     History of Changes
Other Study ID Numbers: NIS-RKR-DUM-2009/1
Study First Received: April 28, 2009
Last Updated: December 2, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
COPD
Symptom
Morning activity
Questionnaire

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

ClinicalTrials.gov processed this record on May 22, 2013