Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
SYMBOL
Prospective, Observational, Multi-center, Non-interventional Study to Assess Patients Perception in SYmptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease
1 other identifier
observational
150
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 3, 2010
December 1, 2010
April 28, 2009
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the perception of COPD Patients in symptoms related to morning activities
At baseline and last visit (after 2~3 months)
Secondary Outcomes (3)
To assess the patient's perception of the variability of symptoms
At baseline and last visit (after 2~3 months)
To describe how patients use their COPD treatments
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…)
At baseline and last visit (after 2~3 months)
Study Arms (2)
1
Morning Symptoms (+)
2
Morning Symptoms (-)
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Daegu, South Korea
Research Site
Gyongiju, South Korea
Research Site
Pohang, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joonwoo Bahn
Astrazenca Korea, Medical Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 28, 2009
First Posted
May 7, 2009
Study Start
May 1, 2009
Study Completion
December 1, 2009
Last Updated
December 3, 2010
Record last verified: 2010-12