Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: BLX-028914; Drug: placebo

• Registration Number: NCT00758446
• Lead Sponsor: Dart NeuroScience, LLC

Brief Summary

This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.

The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 18 to 50 years of age (inclusive), male or female
• Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
• History of pollen-induced seasonal allergic rhinitis but otherwise healthy
• Positive skin prick test for timothy and/or birch allergen
• Sufficient reaction to nasally administered allergen at screening
• Signed informed consent obtained

Exclusion Criteria

• Expected symptoms of seasonal allergic rhinitis during the study period
• Asthma
• Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
• Anti-allergy immunotherapy in the previous two years
• Extensive use of nasal sprays
• Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
• Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
• Smoking within 3 months of first treatment period
• Clinically significant laboratory findings
• Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
• Known hypersensitivity to any constituent of the study medication or placebo
• Participation in any other investigational study in the last three months
• Subject anticipated not being able to adhere to study plan according to investigator judgement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	BLX-028914	BLX-028914 50 mg
B	BLX-028914	BLX-028914 15 mg
C	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Post allergen challenge; Total Nasal Symptom Score(TNSS)	10 minutes after allergen challenge

Trial Locations

Locations (1)

Department of otorhinolaryngology; 🇸🇪 Lund, Sweden