NCT01197690

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 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

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

July 18, 2010

Last Update Submit

September 17, 2015

Conditions

Bronchial Asthma

Keywords

Bronchial asthmalevel of control of asthmafractional exhaled nitric oxide (FeNO)asthma control test (ACT)

Outcome Measures

Primary Outcomes (1)

  • fractional exhaled nitric oxide level

    10 minutes (average time), on the day of enrollment

Secondary Outcomes (1)

  • scores of asthma control test: ACT

    5 minutes (average time), on the day of enrollment

Eligibility Criteria

Age7 Years - 60 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
  • has 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

Study Sites (1)

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Professor Nualanong Visitsunthorn, MD

    Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2010

First Posted

September 9, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

TH(1)