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NCT Number: NCT01241214

Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

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.

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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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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 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.

Treatment and study plan

ACT-129968

Drug

ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily

Cetirizine

Drug

Ceterizine administered once daily

Placebo

Drug

Matching placebo administered twice daily.

Primary outcomes

  1. To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo

    Time frame: Baseline to week 2

Secondary outcomes

  1. To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.

    Time frame: Baseline to week 2

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

Acronym: SAR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2010
Registry last updated
May 15, 2019

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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