AsthmaNCT00353184
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
A study testing Montelukast 5-mg orally added to standard therapy in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast 5-mg orally added to standard therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Feb 2005
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Seeking care in ED for acute asthma exacerbation
- Age 6-14 years inclusive
- Initial FEV1 = 40-70% predicted (defined as moderate severity)
- Consent to participate in study
Who cannot join
- Severe exacerbation requiring immediate therapy as determined by treating clinician
- Pregnancy by history
- Cystic Fibrosis by history
- Tuberculosis
- Gastroesophageal reflux disease requiring medications
- Acute or chronic liver disease
Show all 11Show fewer
- Bronchopulmonary dysplasia
- Premature <34 weeks gestational age by history
- Having used leukotriene-modifying medication within 48 hours
- Having used theophylline within four weeks
- Unable to perform FEV1
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.
Read the detailed description
We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone.
In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours.
We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.
- Conditions
- Asthma
- Being tested
- Montelukast 5-mg orally added to standard therapy
- Keywords
- Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second, FEV1
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 5-mg orally added to standard therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1)
Secondary outcomes (2)
Hospitalization Rate
Relapse Visit Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startSep 2001
- Primary completionOct 2004
- Study completionFeb 2005
Why it stopped: Results of the interim analysis suggested no significant diff between study groups.
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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Ambulatory Pediatric Association
- Investigators
- Kyle A Nelson, MD, Principal investigator, Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. LouisDavid M Jaffe, MD, Study chair, Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353184
- Sponsor's protocol ID
- WUSM HSC #01-0464
- Status last verified
- Feb 2010
- First submitted
- 17 Jul 2006
- Last updated
- 24 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
- ClinicalTrials.gov ID
- NCT00353184
- Acronym / sponsor ID
- WUSM HSC #01-0464
- Conditions
- Asthma
- Keywords
- Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of the interim analysis suggested no significant diff between study groups.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Ambulatory Pediatric Association
- Study start
- Sep 2001
- Primary completion
- Oct 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 18 Jul 2006 (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.
Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.
Detailed description
We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone.
In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours.
We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Seeking care in ED for acute asthma exacerbation
- Age 6-14 years inclusive
- Initial FEV1 = 40-70% predicted (defined as moderate severity)
- Consent to participate in study
Key exclusion criteria (11 listed)
- Severe exacerbation requiring immediate therapy as determined by treating clinician
- Pregnancy by history
- Cystic Fibrosis by history
- Tuberculosis
- Gastroesophageal reflux disease requiring medications
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 |
|---|---|---|
| Montelukast 5-mg orally added to standard therapy | Drug | – |
Primary outcome
Forced Expiratory Volume in One Second (FEV1)
2 secondary outcomes
Hospitalization Rate
Relapse Visit Rate
Results and safety
The study was stopped early (reason given: Results of the interim analysis suggested no significant diff between study groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
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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.
Kyle A Nelson, MD principal investigator
Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis
David M Jaffe, MD study chair
Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast 5-mg orally added to standard therapy in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
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 11 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 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Results of the interim analysis suggested no significant diff between study groups.). 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?
Forced Expiratory Volume in One Second (FEV1). 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 24 Feb 2010.