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NCT Number: NCT01484119

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Investigative Site 7905, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT-129968

Drug

daily tablets

Other names: Setipiprant

Placebo

Drug

matching placebo tablets and capsules

Cetirizine

Drug

daily capsules

Primary outcomes

  1. The mean change in Daytime Nasal Symptom Score

    Time frame: baseline to end of treatment period (2 weeks)

Secondary outcomes

  1. The mean change in other daytime/nighttime symptom scores of allergic rhinitis

    Time frame: baseline to end of treatment period (2 weeks)

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Acronym: SAR

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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