AsthmaMCH-preschoolNCT00550758
Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years
A study testing Methachoine and spirometry in people with Asthma and Recurrent Cough, run by Rambam Health Care Campus.
Trial summary
Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Asthma, Recurrent Cough
- What is being tested?
- Methachoine and spirometry
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 3- to 6-years
- respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9]
- cough duration of more than 4 weeks
- normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing.
Who cannot join
- presence of other chronic respiratory conditions
- emergency room visit or the presence of respiratory infection within the last month
- oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
- bronchodilator taken within 24-hours prior to the test.
About this study
Official title: The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years
Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.
Read the detailed description
We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.
Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).
Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.
- Conditions
- Asthma, Recurrent Cough
- Being tested
- Methachoine, spirometry
- Keywords
- Methacholine challenge; Spirometry, Early childhood
- Medical subject headings
- Asthma, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethachoineDrug
inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)
spirometryDevice
spirometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
Measured: after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startMay 2004
- Study completionApr 2007
Why it stopped: the study has recently ended, all information gathred as planed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Lea Bentur, MD, Study director, Rambam Health Care CampusDaphna Vilozni, PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550758
- Sponsor's protocol ID
- McH-Spir- preschool_CTIL
- Acronym
- MCH-preschool
- Status last verified
- Oct 2007
- First submitted
- 20 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years
- ClinicalTrials.gov ID
- NCT00550758
- Acronym / sponsor ID
- MCH-preschool / McH-Spir- preschool_CTIL
- Conditions
- Asthma, Recurrent Cough
- Keywords
- Methacholine challenge; Spirometry, Early childhood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study has recently ended, all information gathred as planed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.
Detailed description
We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.
Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).
Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age 3- to 6-years
- respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9]
- cough duration of more than 4 weeks
- normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing.
Key exclusion criteria (4 listed)
- presence of other chronic respiratory conditions
- emergency room visit or the presence of respiratory infection within the last month
- oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
- bronchodilator taken within 24-hours prior to the test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methachoineinhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine) | Drug | – |
| spirometryspirometry | Device | – |
Primary outcome
Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
Time frame: after intervention
Results and safety
The study was stopped early (reason given: the study has recently ended, all information gathred as planed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Bentur, MD study director
Rambam Health Care Campus
Daphna Vilozni, PhD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Methachoine and spirometry in people with Asthma and Recurrent Cough, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the study has recently ended, all information gathred as planed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1) (time frame: after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2007; AzTrials last refreshed its copy on 1 Nov 2026.