Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 3

Conditions: Upper Respiratory Tract Infection

Treatments: Drug: Muntelukast; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00551382

20060504(142/06)

142/06

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children 1 to 5 years old without significant health problem.

Exclusion criteria

• 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
• Children who are receiving chronic medications of any kind
• Known allergy to montelukast
• Inability to get an informed consent from a legal guardian.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

500 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Muntelukast

B

Placebo Comparator group

Treatment:

Drug: Placebo