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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04050943
Other study ID # GIRH-CRD2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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