Perception of Symptom Variability in COPD

NCT01753427 | Completed

• 1 other identifier: NIS-RCN-XXX-2012/1
• Study Type: observational
• Target: 1,058
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD,; symptoms,; Non-Interventional study,

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• The impact of COPD symptoms on patient's daily living activities and sleep quality

  Day 1

• The impact of COPD symptoms on morning activities

  Day 1

• Total CAT score

  Day 1

• Total MMRC score

  Day 1

• Patient's perception on COPD and COPD treatments

  Day 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patient, male or female aged 40 years and over and Clinical diagnosis of COPD at least 6 months

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Related Links

• CSR Synopsis
• YAO Wanzhen et al COPD symptom NIS abstract\_2014 APSR. Abstract ID: P-F-090

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

CN (6)