Overview

Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Actelion
Idorsia Pharmaceuticals Ltd.
Treatments:
Cetirizine
Criteria
Inclusion Criteria:

- Males and females aged 18 to 70 years.

- Clinical history of symptomatic seasonal allergic rhinitis associated with mountain
cedar pollen for the last two years.

- Adequate exposure to mountain cedar pollen.

- Positive skin prick test to mountain cedar allergen within 12 months of screening.

- Sufficient nasal symptom score during a run-in period.

Exclusion Criteria:

- Non-allergic rhinitis.

- Bacterial or viral respiratory tract infection.

- Chronic respiratory disorders.

- Asthma requiring treatment other than inhaled short-acting Beta2-agonists.

- Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus
surgery or perforation.

- Smoking within the last year.

- Ongoing or recent treatment for seasonal allergic rhinitis.

- Initiation of allergen immunotherapy within 6 months of screening.