Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

Medical University of Lodz

Status and phase: Unknown; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: placebo; Drug: montelukast; Drug: cetirizine; Drug: montelukast and cetirizine

Study type: Interventional

Funder types: Other

Identifiers

NCT00488176

RNN/94/07KE

Details and patient eligibility

About

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Full description

During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Enrollment: 116 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines

Exclusion criteria

• diagnosis of bronchial asthma
• allergy to perennial allergens
• specific immunotherapy
• other chronic diseases
• tobacco smoking
• acute respiratory tract infection
• excluded drugs: inhaled and systemic glucocorticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

monteluksat sodium

Treatment:

Drug: montelukast

2

Active Comparator group

Description:

cetirizine

Treatment:

Drug: cetirizine

3

Active Comparator group

Description:

montelukast sodium and cetirizine

Treatment:

Drug: montelukast and cetirizine

4

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo