NCT02561351

Brief Summary

The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

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

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

September 16, 2015

Last Update Submit

May 2, 2016

Conditions

Bronchial Asthma

Keywords

bronchial asthmafractional exhaled nitric oxide (FeNO)asthma exacerbation

Outcome Measures

Primary Outcomes (1)

  • Occurrence of asthma exacerbation in the studied cases with different FeNO levels

    Occurrence of asthma exacerbation in 1 year after the study

    1 year

Interventions

FeNO measurementOTHER

FeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit

Eligibility Criteria

Age7 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)

You may qualify if:

  • clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital

You may not qualify if:

  • smoker or past history of smoking
  • chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
  • drink ethanol within 48 hours before enrollment
  • history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahidol University

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 28, 2015

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 3, 2016

Record last verified: 2016-05