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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00758446

Enrollment

Registered

2008-09-25

Start date

2008-09-30

Completion date

2009-01-31

Last updated

2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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.

Interventions

DRUGBLX-028914

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

DRUGplacebo

capsules, p.o, daily, 14 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Post allergen challenge; Total Nasal Symptom Score(TNSS)	10 minutes after allergen challenge

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026