NCT04050943

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

August 7, 2019

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of acute exacerbations

    The rate of exacerbations within 1 year of these patients will be tracked.

    1 year

Secondary Outcomes (4)

  • Survival

    1 year

  • Forced expiratory volume in 1 second

    1 year

  • Health related quality of life: questionnaires

    1 year

  • 6-minute walk test

    1 year

Study Arms (1)

CRD patients

Patients with chronic pulmonary disease like COPD, asthma, bronchiectasis, and etc.

Other: observational cohort

Interventions

Recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

CRD patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Rongchang Chen, MD

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

August 22, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations