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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Investigational drug - Dose 1

Group Type EXPERIMENTAL

ACT-129968

Intervention Type DRUG

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

Investigational drug - Dose 2

Group Type EXPERIMENTAL

ACT-129968

Intervention Type DRUG

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

Investigational drug - Dose 3

Group Type EXPERIMENTAL

ACT-129968

Intervention Type DRUG

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

Investigational Drug - Dose 4

Group Type EXPERIMENTAL

ACT-129968

Intervention Type DRUG

ACT-129968 (Dose 4) \& matching placebo administered orally once daily

Active Matching Reference

Group Type OTHER

Cetirizine

Intervention Type DRUG

Ceterizine administered once daily

Matching Placebo

Group Type PLACEBO_COMPARATOR

ACT-129968

Intervention Type DRUG

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

ACT-129968

Intervention Type DRUG

ACT-129968 (Dose 4) \& matching placebo administered orally once daily

Cetirizine

Intervention Type DRUG

Ceterizine administered once daily

Placebo

Intervention Type DRUG

Matching placebo administered twice daily.

Interventions

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ACT-129968

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

Intervention Type DRUG

ACT-129968

ACT-129968 (Dose 4) \& matching placebo administered orally once daily

Intervention Type DRUG

Cetirizine

Ceterizine administered once daily

Intervention Type DRUG

Placebo

Matching placebo administered twice daily.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No