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)

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574210
• Other study ID #: BILA 2507/EEC
• Secondary ID: P2FZ07001
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: February 2019
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

• Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - History of generalized anaphylaxis requiring medical attention.

• Clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.

Related Conditions & MeSH terms

• Hay Fever
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Rhinoconjunctivitis
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Bilastine
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
• Placebo
Placebo Tablets administered twice per day

Locations

Country	Name	City	State
Canada	Allied Research International - Cetero Research	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Faes Farma, S.A.	Allied Research International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Scores (TNSS)		within 10 days
Secondary	Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC)		witin 10 days