A Cohort of Patients With Chronic Pulmonary Disease

Obstructive Pulmonary Disease Clinical Trial

Official title:

A Long-term, Prospective, Observational Cohort of Patients With Chronic Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050943
• Other study ID #: GIRH-CRD2019
• Status: Recruiting
• Start date: August 22, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Lili Guan, PhD
• Phone: +8613422288665
• Email: dr_nickguan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a longitudinal study of following chronic pulmonary disease patients to observe and predict the clinical outcomes of these patients.

Description:

In patients with chronic pulmonary disease, impaired pulmonary function and limited exercise capacity, is a complex clinical syndrome with a wide range of underlying causes, which may result in worse quality of life and high economic burden. This is a longitudinal study of following chronic pulmonary disease patients, recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80, males and females

2. Patients are diagnosed as the obstructive pulmonary disease according to the clinical practice.

3. Willing to participate in the study.

4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.

2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)

3. Subjects who participated in another trial within 30 days prior to the planned start of the study

4. Subjects with cancer or have had cancer in the 5 years prior to study entry.

Related Conditions & MeSH terms

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

Intervention

Other:
• observational cohort
Recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of acute exacerbations	The rate of exacerbations within 1 year of these patients will be tracked.	1 year
Secondary	Survival	The rate of survival within 1 year of these patients will be tracked.	1 year
Secondary	Forced expiratory volume in 1 second	Forced expiratory volume in 1 second is a marker used to measure lung function and can help you monitor your lung diseases over time.	1 year
Secondary	Health related quality of life: questionnaires	Using questionnaires to reflect the patients' health related quality of life.; The questionnaires include: SF-36 (scores range between 0 and 100 and higher scores are attributed to better quality of life.); St. George's Respiratory Questionnaire (scores range between 0 and 100 and higher scores are attributed to worse quality of life.); Severe Respiratory Insufficiency Questionnaire (scores range between 0 and 100 and higher scores are attributed to better quality of life.)	1 year
Secondary	6-minute walk test	The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.	1 year