Status:
COMPLETED
Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT01241214
Start Date
November 1 2010
End Date
February 1 2011
Last Update
May 15 2019
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