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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01484119

Run by

Idorsia Pharmaceuticals Ltd.

People needed

630

Starts

2011-12-01

Expected to finish

2012-03-01

Last updated by the study team

2018-09-28

Who can join

Age: 12 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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