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

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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.


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.
We found this trial at
4
sites
San Antonio, Texas 78229
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Austin, Texas 78731
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Austin, TX
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Kerrville, Texas 78028
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Kerrville, TX
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New Braunfels, Texas 78130
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New Braunfels, TX
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