A Cohort of Patients With Chronic Pulmonary Disease | NCT04050943

Studies
A Cohort of Patients With Chronic Pulmonary Disease

NCT04050943

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Status

Unknown status

Last Update Posted

Oct 22, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Obstructive Pulmonary Disease

Interventions

observational cohort

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2019Actual

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

Aug 7, 2019

First Submission Date that Met QC Criteria

Aug 8, 2019

First Posted Date

Aug 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2019

Last Update Posted Date

Oct 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guan Lili, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRD patients		Patients with chronic pulmonary disease like COPD, asthma, bronchiectasis, and etc.	Other: observational cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational cohort	Other	Recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.	CRD patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80, males and females
Patients are diagnosed as the obstructive pulmonary disease according to the clinical practice.
Willing to participate in the study.
Being able to provide informed consent.

Exclusion Criteria:

Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
Subjects who participated in another trial within 30 days prior to the planned start of the study
Subjects with cancer or have had cancer in the 5 years prior to study entry.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lili Guan, PhD	Contact	+8613422288665		dr_nickguan@163.com

Overall Officials

Name	Affiliation	Role
Rongchang Chen, MD	The First Affiliated Hospital of Guangzhou Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Institute of Respiratory Disease	Recruiting	Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D008173	Lung Diseases, Obstructive

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided