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

This study has been completed.
Sponsor:
Collaborator:
Orexo AB
Information provided by (Responsible Party):
Dart NeuroScience, LLC
ClinicalTrials.gov Identifier:
NCT00758446
First received: September 22, 2008
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Drug: BLX-028914
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis

Further study details as provided by Dart NeuroScience, LLC:

Primary Outcome Measures:
  • Post allergen challenge; Total Nasal Symptom Score(TNSS) [ Time Frame: 10 minutes after allergen challenge ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
BLX-028914 50 mg
 Drug: BLX-028914
50 mg capsules, p.o, daily, 14 days
Experimental: B
BLX-028914 15 mg
 Drug: BLX-028914
15 mg capsules, p.o, daily, 14 days
Placebo Comparator: C
Placebo
 Drug: placebo
capsules, p.o, daily, 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758446

Locations
Sweden
Department of otorhinolaryngology
Lund, Sweden, 221 85
Sponsors and Collaborators
Dart NeuroScience, LLC
Orexo AB
Investigators
Principal Investigator: Lennart Greiff, MD, PhD Department of otorhinolaryngology
  More Information

No publications provided

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT00758446     History of Changes
Other Study ID Numbers: OX914-001
Study First Received: September 22, 2008
Last Updated: March 12, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013