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

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.

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Research Site
  • Gyongiju, Korea, Republic of
    • Research Site
  • Pohang, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Morning Symptoms (+)
2; Morning Symptoms (-)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Joonwoo Bahn, Astrazenca Korea, Medical Department

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: COPD; Questionnaire; Symptom; Morning activity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NIS-RKR-DUM-2009/1