A Cohort of Patients With Chronic Pulmonary Disease

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

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

Study Overview

• Status: Unknown
• Conditions: Obstructive Pulmonary Disease
• Intervention / Treatment: Other: observational cohort

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Lili Guan, PhD; Phone Number: +8613422288665; Email: dr_nickguan@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou Institute of Respiratory Disease
      • Contact: Rongchang Chen; Phone Number: +8615622236759; Email: chenrcstatekeylab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a longitudinal study of following obstructive pulmonary disease patients from the outpatient clinic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRD patients; Patients with chronic pulmonary disease like COPD, asthma, bronchiectasis, and etc.	Other: observational cohort; Recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute exacerbations	The rate of exacerbations within 1 year of these patients will be tracked.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	The rate of survival within 1 year of these patients will be tracked.	1 year
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Rongchang Chen, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: GIRH-CRD2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No