A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

UCB

Status and phase: Completed; Phase 2

Conditions: Rhinitis; Seasonal; Allergic

Treatments: Drug: Placebo drops; Drug: Placebo tablets matching to cetirizine; Drug: Cetirizine tablets; Drug: Placebo tablets matching to levocetirizine; Drug: Levocetirizine tablets; Drug: Levocetirizine drops; Drug: Cetirizine drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291642

A00412

Details and patient eligibility

About

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

Enrollment: 551 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
• Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
• Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by 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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551 participants in 5 patient groups, including a placebo group

Placebo (PBO)

Placebo Comparator group

Description:

A single dose of placebo was administered orally on Day 1.

Treatment:

Drug: Placebo drops

Drug: Placebo tablets matching to cetirizine

Drug: Placebo tablets matching to levocetirizine

Levocetirizine (LCTZ) 2.5 mg

Experimental group

Description:

A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.

Treatment:

Drug: Levocetirizine drops

Levocetirizine (LCTZ) 5 mg

Experimental group

Description:

A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.

Treatment:

Drug: Levocetirizine tablets

Cetirizine (CTZ) 5 mg

Experimental group

Description:

A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.

Treatment:

Drug: Cetirizine drops

Cetirizine (CTZ) 10 mg

Experimental group

Description:

A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.

Treatment:

Drug: Cetirizine tablets