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

COPD Clinical Trial

— SYMBOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894426
• Other study ID #: NIS-RKR-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: December 2, 2010
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Gyongiju
Korea, Republic of	Research Site	Pohang

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the perception of COPD Patients in symptoms related to morning activities		At baseline and last visit (after 2~3 months)	No
Secondary	To assess the patient's perception of the variability of symptoms		At baseline and last visit (after 2~3 months)	No
Secondary	To describe how patients use their COPD treatments		At baseline and last visit (after 2~3 months)	No
Secondary	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)	No