Upper Respiratory Tract InfectionPhase 3NCT00551382
Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study
A Phase 3 study testing Muntelukast in people with Upper Respiratory Tract Infection, run by Assaf-Harofeh Medical Center at 3 sites in Israel.
Trial summary
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Muntelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2007to Jun 2010
- Phase
- Phase 3
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 1 to 5 years old without significant health problem.
Who cannot join
- A previous history of wheezing (requiring treatment with bronchodilators in the last 3 month or more than one treatment in the last year)
- Hospital admission due to reactive air way disease
- Prophylactic use of montelukast or steroids
- Chronic cardiac or respiratory disease
- Presence of acute respiratory tract infection within the 7 days before consideration for the study
- History of allergic Rhinitis
Show all 9Show fewer
- Children who are receiving chronic medications of any kind
- Known allergy to montelukast
- Inability to get an informed consent from a legal guardian.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Kupat Cholim Clalit
Lod
Al Garushi
Al Garushi, MD
- Recruiting
Kupat Cholim Clalit
Ramla
Zachi Lotem
- Recruiting
Assaf Harofeh
Tsrifin, 70300
Berkovitch, 97289779152
Mati Berkovitch, MD
About this study
Official title: Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable.
Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI.
Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Muntelukast, Placebo
- Keywords
- Montelukast, Upper respiratory tract infection, leukotriene, Children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MuntelukastDrug
Also called Singulair
Tablets or granules; 4 mg once a day for 12 weeks
PlaceboDrug
Look alike tablets or granules 1 per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Muntelukast |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and duration of URI episodes
Measured: 3 month
Secondary outcomes (1)
Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Mati Berkovitch, MD, Principal investigator, Assaf-Harofeh Medical CenterEran Kozer, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551382
- Sponsor's protocol ID
- 142/06
- Other IDs
- 20060504(142/06)
- Status last verified
- Mar 2010
- First submitted
- 30 Oct 2007
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT00551382
- Acronym / sponsor ID
- 142/06
- Conditions
- Upper Respiratory Tract Infection
- Keywords
- Montelukast, Upper respiratory tract infection, leukotriene, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 31 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.
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable.
Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI.
Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Muntelukast |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 1 to 5 years old without significant health problem.
Key exclusion criteria (9 listed)
- A previous history of wheezing (requiring treatment with bronchodilators in the last 3 month or more than one treatment in the last year)
- Hospital admission due to reactive air way disease
- Prophylactic use of montelukast or steroids
- Chronic cardiac or respiratory disease
- Presence of acute respiratory tract infection within the 7 days before consideration for the study
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 |
|---|---|---|
| MuntelukastAlso: SingulairTablets or granules; 4 mg once a day for 12 weeks | Drug | A |
| PlaceboLook alike tablets or granules 1 per day for 12 weeks | Drug | B |
Primary outcome
The number and duration of URI episodes
Time frame: 3 month
1 secondary outcome
Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug.
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
Mati Berkovitch, MD principal investigator
Assaf-Harofeh Medical Center
Eran Kozer, MD principal investigator
Assaf-Harofeh Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Muntelukast in people with Upper Respiratory Tract Infection, run by Assaf-Harofeh Medical Center at 3 sites in Israel.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mati Berkovitch, MD (972 8 9779152, mberkovitch@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and duration of URI episodes (time frame: 3 month). 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 17 Mar 2010; AzTrials last refreshed its copy on 8 Nov 2026.