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COMPLETEDPHASE2

PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

A Randomized, Double-blind, Placebo-controlled, 5-arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode

NCT00574210•Faes Farma, S.A.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical history of SAR for the last two ragweed allergy seasons.
•A positive skin test within 12 months of screening to ragweed allergen.
•A minimum qualifying symptom score on both Visits, 2 and 3.
•Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.

Exclusion Criteria

•Women who are pregnant, breastfeeding, or planning a pregnancy.
•History of more than mild asthma.
•History of clinically significant (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
•Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
•An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
•A need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
•Currently taking monoamine oxidase (MAO) inhibitors.
•Taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to Visit 1.
•Taken any antihistamine within seven days prior to Visit 1 skin testing.
•Known current alcohol or drug abuse.
+2 more criteria

Locations (1)

Allied Research International - Cetero Research

Mississauga, Ontario, Canada

Key Dates

Start Date

October 1, 2007

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

February 15, 2019

Enrollment

502

ACTUAL participants

Conditions

Seasonal Allergic RhinitisHay FeverRhinoconjunctivitis

Interventions

Bilastine

DRUG

Placebo

DRUG

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

NCT04435990

Rhinitis, AllergicRhinoconjunctivitis+1 more

View study

RECRUITINGPHASE4

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

NCT06778213

Allergic Rhinoconjunctivitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

Retrospective Study Evaluating the Effectiveness and Safety of Immunotherapy With Clustoid Max Forte

Study of BLU-808 in Allergic Rhinoconjunctivitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients