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OpenTrials
Completed

NCT Number: NCT00758446

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of otorhinolaryngology

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLX-028914

Drug

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

Placebo

Drug

capsules, p.o, daily, 14 days

Primary outcomes

  1. Post allergen challenge; Total Nasal Symptom Score(TNSS)

    Time frame: 10 minutes after allergen challenge

Sponsors and collaborators

Lead sponsor

Dart NeuroScience, LLC

Industry

Collaborators

  • Orexo AB

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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