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
- Conditions
- Allergic rhinitis (LLT) Code 10001723MedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis
- Registration Number
- EUCTR2008-001179-30-SE
- Lead Sponsor
- Orexo AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. 18 to 50 years of age (inclusive), male or female
2. Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
3. History of pollen-induced seasonal allergic rhinitis for at least 2 years but otherwise healthy
4. Seasonal allergic rhinitis with symptoms provoked by timothy and/or birch pollen allergens.
5. Positive skin prick test for timothy and/or birch allergen at screening visit or within two years prior to the screening visit
6. Sufficient reaction to nasally administered allergen at screening
7. Signed informed consent obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Perennial allergic rhinitis except for
a. cat and/or dog sensitivity under the condition that these subjects are not exposed to cats and dogs
b. house dust mite sensitivity under the condition that these subjects are not exposed to house dust mite (e.g. sanitized home environment)
2. Expected symptoms of seasonal allergic rhinitis during the study period according to medical history (e.g. mugwort allergy during mugwort pollen season)
3. Asthma
4. Nasal anatomical deviations, as judged by the investigator
5. Ongoing nasal symptoms as judged by the investigator
6. Ongoing upper respiratory tract infection
7. Anti-allergy immunotherapy in the previous two years
8. Extensive use of nasal sprays as judged by the investigator
9. Any medication except for contraceptives, during their last five half-lives prior to the first treatment period except for occasional OTC analgesics. Specific washout periods apply to the following anti-allergy treatments:
-Depot injections of corticosteroids: 12 months prior to screening visit
-Intranasal and systemic corticosteroids: 1 month prior to screening visit
-Intranasal cromolyn: 2 weeks prior to screening visit
-Intranasal or systemic decongestants: 3 days prior to screening visit
-Intranasal or systemic antihistamines: 3 days prior to screening visit
-Loratadine: 10 days prior to screening visit
10. Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John’s-wort) that may effect the enzyme CYP3A4 within 1 week prior to first treatment visit.
11. Recent intake of alcohol prior to screening visit according to alcohol breath test
12. Smoking within 3 months of first treatment period
13. Positive for HIV according to diagnostic test
14. Positive for Hepatitis B or C according to diagnostic tests
15. Clinically significant laboratory findings as judged by the investigator
16. Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, per oral contraceptive, hormone injections or implants).
17. Known hypersensitivity to any constituent of the study medication or placebo as specified in section 3.4.1.1
18. Participation in any other investigational study in the last three months prior to the screening visit
19. Subject anticipated not being able to adhere to study plan according to investigator judgement
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To demonstrate superiority of BLX-028914 50 mg/day to placebo regarding the efficacy on total nasal symptoms 10 min after allergen challenge on treatment days 11 - 13;Secondary Objective: •To evaluate the efficacy of BLX-028914 50 and 15 mg/day on nasal symptoms, treatment days 11-13 compared to placebo<br><br>•To evaluate the efficacy of BLX-028914 50 and 15 mg/day on peak nasal inspiratory flow (PNIF), treatment days 11-13 compared to placebo<br><br>•To evaluate the effects of BLX-028914, 50 and 15 mg/day on nasal mucosal inflammatory respons treatment on day 14, compared to placebo (as assessed by a2-macroglobulin, eosinophil cationic protein (ECP) and tryptase levels in nasal lavage)<br><br>•To evaluate the safety and tolerability of treatment with BLX-028914<br>;Primary end point(s): Post allergen challenge TNSS, day 11 - 13: The mean of the TNSS collected 10 min after allergen challenge on treatment days 11, 12 and 13.
- Secondary Outcome Measures
Name Time Method