Clinical trial NCT01484119: Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: seasonal allergic rhinitis
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 630
Sex: ALL
Minimum age (years): 12
Maximum age (years): 76
Standard ages: CHILD
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 ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean change in Daytime Nasal Symptom Score
timeFrame: baseline to end of treatment period (2 weeks)
Secondary outcomes:
measure: The mean change in other daytime/nighttime symptom scores of allergic rhinitis
timeFrame: baseline to end of treatment period (2 weeks)
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: Michael Grabo, PhD
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.