Status:
COMPLETED
Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
12-76 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT01484119
Start Date
December 1 2011
End Date
March 1 2012
Last Update
September 28 2018
Active Locations (7)
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1
Clinical Investigative Site 7905
Austin, Texas, United States, 78731
2
Clinical Investigative Site 7907
Kerrville, Texas, United States, 78028
3
Clinical Investigative Site 7903
New Braunfels, Texas, United States, 78130
4
Clinical Investigative Site 7901
San Antonio, Texas, United States, 78229