Perception of Symptom Variability in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Perception of Symptom Variability in Chinese COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753427
• Other study ID #: NIS-RCN-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: June 14, 2016
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Provision of subject informed consent

• Out-patient

• Clinical diagnosis of COPD at least 6 months

• Lung function based on data available within 3 months in medical records confirming FEV1<80% normal predicted (post-bronchodilator) and FEV1/FVC<0.7 (post-bronchodilator)

Exclusion Criteria:

• Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire

• Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency

• History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Chengdu	Sichuan
China	Research Site	Guangzhou	Guangdong
China	Research Site	Shanghai	Shanghai
China	Research Site	Tianjin	Tianjin
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The variability of symptoms due to COPD throughout the day	To ask subject, which symptoms(breathlessness, chest tightness, coughing, wheezing, phlegm)is COPD symptoms and exist throughout the day; To ask subject , whether COPD symptoms variability throughout the day exists or not ; To ask subject , which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most likely occurring time of these symptoms; To ask subject , Which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most troublesome time of these symptoms.	Day 1	No
Secondary	The impact of COPD symptoms on patient's daily living activities and sleep quality	To ask subject, Whether essential daily activities affected by COPD symptoms and the type of following: going up and downstairs, Going out of shopping, doing sport/exercise, doing housework, or all of these; To ask subject, Whether sleep quality affected by COPD symptoms and the type of following: difficulty falling sleep, frequent waking during night, early waking in the morning, or all of these	Day 1	No
Secondary	The impact of COPD symptoms on morning activities	To ask subject, When [getting out of bed, dressing, washing, eating breakfast, morning activity after breakfast (indoor activity, including housework) , morning exercise (outdoor activity, such as walking, sport, etc)] the essential morning activities affected by COPD symptoms: To ask subject, The extent of these morning activities affected: not at all, a little, moderate, severe, extremely severe resulting to feel difficult to complete independently, extremely severe resulting to complete under others help or cannot complete at all	Day 1	No
Secondary	Total CAT score	CAT (COPD assessment test) has a broader coverage of the impact of COPD on the patient's daily life and well-being.	Day 1	No
Secondary	Total MMRC score	MMRC (Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness) assesses disability due to breathlessness.	Day 1	No
Secondary	Patient's perception on COPD and COPD treatments	To ask subject, Seek for treatment only when symptoms occur/worsening or regularly visit physician and take medicine(s); To ask subject, Whether Knowing about how and when to use their medications; To ask subject, Usually taking their medication(s) required by physician to be used in the morning at what time: before getting out of bed, within 30 minutes after getting out of bed, within 30 minutes to 1 hour after getting out of bed, over 1 hour after getting out of bed, no regular time	Day 1	No

External Links

•   CSR Synopsis
•   YAO Wanzhen et al COPD symptom NIS abstract_2014 APSR. Abstract ID: P-F-090