The study is a proof-of-concept study with the objective to investigate whether rhCC10, administered intranasally, can affect the response to an allergen provocation test in subjects with allergic rhinitis.
Conditions
Interventions
Product Name: Recombinant human Clara cell protein 10 (rhCC10)
Product Code: rhCC10
Pharmaceutical Form: Nasal spray, solution
Pharmaceutical form of the placebo: Nasal spray, solution
Route of admini
Sponsors
LTB4 Sweden AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) Male subjects, aged 18-50 years, Body Mass Index between 18 and 28 kg/m2, with a history of birch and/or timothy pollen-induced seasonal allergic rhinitis for at least the previous 2 years and otherwise healthy. b) Elevated specific IgE to at least one aero allergen or at least one positive skin prick test (SPT). c)Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT. d) In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits. e) Subject is capable of understanding and signing an informed consent form. 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
Exclusion criteria
Exclusion criteria: a) Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these subjects are not exposed to cats and dogs. b) Other nasal disease (structural abnormalities of the nose, rhinosinositis, nasal polyposis). c) Any upper respiratory tract infection during the period of 2 weeks before the start of the study. d) Current treatment and/or treatment within 4 weeks of enrolment with intranasal, inhaled or systemic glucocorticosteroids, ß2-adrenergic receptor agonists, or any other anti-inflammatory medication. e) Bacterial or fungal infection within the past month. f) Contraindications to allergen or histamine challenge test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of repeated doses of intranasal rhCC10 administration in subjects with allergic rhinitis. In addition, the onset of action of the study drug will be evaluated over the 7-day treatment period. ;Secondary Objective: •To evaluate the safety and tolerability of repeated doses of intranasal rhCC10 in allergic subjects, •To characterize the effects of rhCC10 treatment on individual nasal symptom scores, peak nasal inspiratory flow (PNIF), and laboratory analyses of nasal lavage fluid, •To evaluate the effects of rhCC10 after histamine challenge.;Primary end point(s): Means of total nasal symptom scores (TNSS) during the last 3 days of the challenge period of 7 days. Difference in TNSS between rhCC10 treatment and placebo treatment will be assessed and TNSS will be evaluated 10 minutes after each allergen challenge and daily in the morning and in the evening. | — |
Countries
Sweden
Outcome results
None listed