Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

UCB

Status and phase: Completed; Phase 4

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Montelukast; Drug: Placebo; Drug: Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00295022

A00414

Details and patient eligibility

About

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
• Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol

Exclusion criteria

• Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
• Have used forbidden concomitant medications as defined by the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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418 participants in 3 patient groups, including a placebo group

Placebo (PBO)

Placebo Comparator group

Description:

Placebo was administered orally on Days 1 and 2.

Treatment:

Drug: Placebo

Montelukast (MLKT)

Experimental group

Description:

10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.

Treatment:

Drug: Montelukast

Levocetirizine (LCTZ)

Experimental group

Description:

5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.

Treatment:

Drug: Levocetirizine