Clinical trial NCT01241214: Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal allergic rhinitis
SAR
Allergic rhinitis
Allergies
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
timeFrame: Baseline to week 2
Secondary outcomes:
measure: To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.
timeFrame: Baseline to week 2
Other outcomes:
Locations:
city: Austin
country: United States
facility: Clinical Investigative Site 7905
state: Texas
city: Kerrville
country: United States
facility: Clinical Investigative Site 7907
state: Texas
city: New Braunfels
country: United States
facility: Clinical Investigative Site 7903
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site 7901
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site 7902
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site 7904
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site 7906
state: Texas
Study officials:
affiliation: Actelion
name: Sara Mangialaio, MD
role: STUDY_DIRECTOR
References:
citation: Ratner P, Andrews CP, Hampel FC, Martin B, Mohar DE, Bourrelly D, Danaietash P, Mangialaio S, Dingemanse J, Hmissi A, van Bavel J. Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies. Allergy Asthma Clin Immunol. 2017 Apr 4;13:18. doi: 10.1186/s13223-017-0183-z. eCollection 2017.