Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis
Status: | Completed |
---|---|
Conditions: | Allergy |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 12 - 76 |
Updated: | 9/30/2018 |
Start Date: | December 2011 |
End Date: | March 2012 |
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
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.
patients with seasonal allergic rhinitis, due to mountain cedar pollen.
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.
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