BronchiolitisNCT00524693
Montelukast in Acute RSV Bronchiolitis
A study testing Montelukast in people with Bronchiolitis, run by Ziv Hospital.
Trial summary
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. Read more about this study
- Who is it for?
- Ages 4 weeks to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to not given
- 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 4 weeks to 2 years
- All sexes
- Child
Who may be able to join
- Age > 4 weeks < 2 years
- Duration of respiratory symptoms < 4 days
- Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
- First episode of wheezing or shortness of breath
- Randomization within 12 hours of admission
- No need for steroid treatment in the ward
- Informed consent
Who cannot join
- A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
- Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
About this study
Official title: A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Montelukast, Placebo granules
- Keywords
- Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair©
4mg sachets
Placebo granulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 4mg Singulair© sachets Receives: Drug: Montelukast |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Collaborators
- Wolfson Medical Center
- Investigators
- Israel Amirav, MD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524693
- Sponsor's protocol ID
- HP-146-R
- Status last verified
- Sep 2007
- First submitted
- 4 Sep 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.
PubMed 18984650
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
- ClinicalTrials.gov ID
- NCT00524693
- Acronym / sponsor ID
- HP-146-R
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, controlled clinical trial, pediatrics, Infants, montelukast, Respiratory syncytial virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Collaborators
- Wolfson Medical Center
- Study start
- Jan 2006
- First posted
- 5 Sep 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.
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Montelukast4mg Singulair© sachets |
| 2 | Placebo comparator | Drug: Placebo granules |
Who may qualify
- Ages
- 4 weeks to 2 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age > 4 weeks < 2 years
- Duration of respiratory symptoms < 4 days
- Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
- First episode of wheezing or shortness of breath
- Randomization within 12 hours of admission
Key exclusion criteria (2 listed)
- A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
- Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
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 |
|---|---|---|
| MontelukastAlso: Singulair©4mg sachets | Drug | 1 |
| Placebo granules | Drug | 2 |
Primary outcome
Length of stay
Time frame: hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2007.
- Derived from this study: PubMed 18984650Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.
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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.
Israel Amirav, MD principal investigator
Ziv Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast in people with Bronchiolitis, run by Ziv Hospital.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of stay (time frame: hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524693, which also lists 1 linked publication.
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 5 Sep 2007.