Conditions: Rhinitis Allergic Seasonal
Keywords: Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 551
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: A single dose of placebo was administered orally on Day 1. arm 2: A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. arm 3: A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. arm 4: A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. arm 5: A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.

Interventions: intervention 1: Placebo drops intervention 2: Placebo tablets matching to levocetirizine intervention 3: Placebo tablets matching to cetirizine intervention 4: Levocetirizine drops intervention 5: Levocetirizine tablets intervention 6: Cetirizine drops intervention 7: Cetirizine tablets
Intervention descriptions: intervention 1: * Pharmaceutical form: Drops for oral administration
* Route of administration: Oral use intervention 2: * Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use intervention 3: * Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use intervention 4: * Pharmaceutical form: Drops for oral administration
* Concentration: 5 mg/ml
* Route of administration: Oral use intervention 5: * Pharmaceutical form: Tablets for oral administration
* Concentration: 5 mg
* Route of administration: Oral use intervention 6: * Pharmaceutical form: Drops for oral administration
* Concentration: 10 mg/ml
* Route of administration: Oral use intervention 7: * Pharmaceutical form: Tablets for oral administration
* Concentration: 10 mg
* Route of administration: Oral use

Protocol document: