E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
•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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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, β2-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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |