Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.

Official Title
-----------------
Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: ACT-129968
* Drug: Placebo
* Drug: Cetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years. Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or > or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period. Exclusion Criteria Non-allergic rhinitis. Severe physical nasal obstruction. Acute or significant chronic sinusitis. Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear. Ongoing chronic respiratory disorders. Asthma requiring use of short-acting beta2-agonists > 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists. Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma. Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit. Ocular surgery within the 8 weeks prior to the Screening Visit. Ocular infections (bacterial or viral) within the 4 weeks before screening. Use of forbidden medications (prescribed or over-the-counter [OTC]) Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 76 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational Drug<br>ACT-129968 | Drug: ACT-129968<br>* daily tablets<br>* Other names: Setipiprant;|
| Placebo Comparator: Comparative Drug<br>matching placebo tablets and capsules | Drug: Placebo<br>* matching placebo tablets and capsules<br>|
| Active Comparator: Reference Drug<br>Cetirizine | Drug: Cetirizine<br>* daily capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in Daytime Nasal Symptom Score |  | baseline to end of treatment period (2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in other daytime/nighttime symptom scores of allergic rhinitis |  | baseline to end of treatment period (2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seasonal allergic rhinitis