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

NCT ID: NCT00758446

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-01-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

BLX-028914 50 mg

Group Type: EXPERIMENTAL

BLX-028914

Intervention Type: DRUG

50 mg capsules, p.o, daily, 14 days

B

BLX-028914 15 mg

Group Type: EXPERIMENTAL

BLX-028914

Intervention Type: DRUG

15 mg capsules, p.o, daily, 14 days

C

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

capsules, p.o, daily, 14 days

Interventions

BLX-028914

50 mg capsules, p.o, daily, 14 days

Intervention Type: DRUG

BLX-028914

15 mg capsules, p.o, daily, 14 days

Intervention Type: DRUG

placebo

capsules, p.o, daily, 14 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orexo AB

INDUSTRY

Sponsor Role: collaborator

Dart NeuroScience, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lennart Greiff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of otorhinolaryngology

Locations

Department of otorhinolaryngology

Lund, , Sweden

Countries

Sweden

Other Identifiers

OX914-001

Identifier Type: -

Identifier Source: org_study_id