A double-blind, randomised, placebo-controlled, crossover, allergen challenge study, evaluating the safety, tolerability and effects of intranasal administration of recombinant human Clara Cell 10 kDa (rhCC10) protein in subjects with allergic rhinitis

• Conditions: 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.

• Registration Number: EUCTR2006-005420-17-SE
• Lead Sponsor: TB4 Sweden AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified