NCT04125316

Brief Summary

This study aims to assess the level of FeNO in Chinese asthma patients with respect to the different levels of asthma control over 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

September 27, 2019

Last Update Submit

February 7, 2023

Conditions

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • the level of FeNO

    to assess the level of FeNO in Chinese asthma patients with respect to the different levels of asthma control over a period of 1 year.

    1 year

Secondary Outcomes (1)

  • FeNO and risk of asthma exacerbation

    1 year

Study Arms (1)

Asthma

Asthma patients

Other: Observation, no intervention

Interventions

Observational study, no intervnetion

Also known as: No intervention
Asthma

Eligibility Criteria

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

Asthma patients attending clinic at the Prince of Wales Hospital in Hong Kong

You may qualify if:

  • Chinese subjects aged between 18 and 90 years, and
  • Have a diagnosis of asthma according to The Global Initiative for Asthma (GINA) guideline 2019. Asthma is defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 200 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable.

You may not qualify if:

  • Patients with respiratory diseases with other known respiratory diseases including chronic obstructive pulmonary disease, bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer
  • Individuals older than 40 years with a smoking history of more than 10 pack-years
  • Patients currently randomized in other clinical studies
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Asthma

Interventions

Observation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • David Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Associate Professor

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 14, 2019

Study Start

October 15, 2019

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

No plan

Locations