A Cohort of Patients With Chronic Pulmonary Disease

• Conditions: Obstructive Pulmonary Disease
• Interventions: Other: observational cohort

• Registration Number: NCT04050943
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Study Start: 2019-08-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRD patients	observational cohort	Patients with chronic pulmonary disease like COPD, asthma, bronchiectasis, and etc.

Primary Outcome Measures

Name	Time	Method
Rate of acute exacerbations	1 year	The rate of exacerbations within 1 year of these patients will be tracked.

Secondary Outcome Measures

Name	Time	Method
Survival	1 year	The rate of survival within 1 year of these patients will be tracked.
Health related quality of life: questionnaires	1 year	Using questionnaires to reflect the patients' health related quality of life.; The questionnaires include: 1. SF-36 (scores range between 0 and 100 and higher scores are attributed to better quality of life.); 2. St. George's Respiratory Questionnaire (scores range between 0 and 100 and higher scores are attributed to worse quality of life.); 3. Severe Respiratory Insufficiency Questionnaire (scores range between 0 and 100 and higher scores are attributed to better quality of life.)
6-minute walk test	1 year	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.
Forced expiratory volume in 1 second	1 year	Forced expiratory volume in 1 second is a marker used to measure lung function and can help you monitor your lung diseases over time.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China