Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

— SAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484119
• Other study ID #: AC-060B307
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• ACT-129968
daily tablets
• Placebo
matching placebo tablets and capsules
• Cetirizine
daily capsules

Locations

Country	Name	City	State
United States	Clinical Investigative Site 7905	Austin	Texas
United States	Clinical Investigative Site 7907	Kerrville	Texas
United States	Clinical Investigative Site 7903	New Braunfels	Texas
United States	Clinical Investigative Site 7901	San Antonio	Texas
United States	Clinical Investigative Site 7902	San Antonio	Texas
United States	Clinical Investigative Site 7904	San Antonio	Texas
United States	Clinical Investigative Site 7906	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in Daytime Nasal Symptom Score		baseline to end of treatment period (2 weeks)
Secondary	The mean change in other daytime/nighttime symptom scores of allergic rhinitis		baseline to end of treatment period (2 weeks)