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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
BLX-028914
BLX-028914
placebo
Sponsored by
Dart NeuroScience, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of otorhinolaryngology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

BLX-028914 50 mg

BLX-028914 15 mg

Placebo

Outcomes

Primary Outcome Measures

Post allergen challenge; Total Nasal Symptom Score(TNSS)

Secondary Outcome Measures

Full Information

First Posted
September 22, 2008
Last Updated
March 12, 2013
Sponsor
Dart NeuroScience, LLC
Collaborators
Orexo AB
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1. Study Identification

Unique Protocol Identification Number
NCT00758446
Brief Title
Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dart NeuroScience, LLC
Collaborators
Orexo AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
BLX-028914 50 mg
Arm Title
B
Arm Type
Experimental
Arm Description
BLX-028914 15 mg
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BLX-028914
Intervention Description
50 mg capsules, p.o, daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BLX-028914
Intervention Description
15 mg capsules, p.o, daily, 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsules, p.o, daily, 14 days
Primary Outcome Measure Information:
Title
Post allergen challenge; Total Nasal Symptom Score(TNSS)
Time Frame
10 minutes after allergen challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Greiff, MD, PhD
Organizational Affiliation
Department of otorhinolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of otorhinolaryngology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

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

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