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

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ClinicalTrials.gov Identifier: NCT00758446
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Orexo AB
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: BLX-028914 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Post allergen challenge; Total Nasal Symptom Score(TNSS) [ Time Frame: 10 minutes after allergen challenge ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT00758446     History of Changes
Other Study ID Numbers: OX914-001
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases