E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | seasonal allergic rhinitis | |
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 efficacy and safety of ME3301 vs placebo in subjects with seasonal allergic rhinitis (SAR) exposed to allergen for 6 hours in the Vienna Challenge Chamber (VCC), commencing 30 minutes after dosing on day 8. | |
E.2.2 | Secondary objectives of the trial | To evaluate the dose relationship for ME3301 in the Total Nasal Symptom Score (TNSS-1) Evaluate the efficacy of ME3301 vs. placebo on the TNSS-2, TNSS-3, total non-nasal symptom score (TNNSS) and total symptom score (TSS) in subjects with seasonal allergic rhinitis exposed to allergen for 6 hours in the VCC (Definitions are provided in the protocol.) Evaluate the efficacy of ME3301 vs. placebo on nasal flow and nasal secretion in subjects with seasonal allergic rhinitis exposed to allergen for 6 hours in the VCC. Evaluate the efficacy of ME3301 vs. placebo on nasal symptoms (sneezing, rhinorrhoea, nasal congestion and nasal itching), and other symptoms (eye tearing, eye itching, eye redness, itching of ears and/or palate) in subjects with seasonal allergic rhinitis exposed to allergen for 6 hours in the VCC. Assess nasal congestion by the visual examination of digital nasal endoscopic images Assess the safety and tolerability of ME3301 under repeat-dose conditions | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | Male or female outpatients, aged 18-64 years. Have documented history of SAR for at least 2 years. Have Positive skin prick test (i.e. wheal diameter 3 mm larger than that produced by the negative control) and a positive RAST (class 2 or greater) to grass pollen (dactylis, rye grass or phleum) at Screening or within the last 12 months. Have TNSS-1 of 2 or less before allergen challenge at Screening Visit. Have TNSS-1 of 6 or greater at 2 or more time points within the 2-hour allergen challenge at the Screening Visit. Have nasal congestion score of 2 or greater within the 2-hour allergen challenge at the Screening Visit. | |
E.4 | Principal exclusion criteria | Active allergic rhinitis in the 2 weeks preceding the screening. Asthma, with the exception of mild intermittent asthma which does not currently require treatment, or other active, acute or chronic pulmonary disorder which is documented by history, physical examination or chest X-ray. Use of the medication/ therapies such as Corticosteroids, Cromones, Antihistamines and Decongestants, during the periods specified. Have currently, or have had in the 4 weeks preceding the Screening Visit, an upper respiratory infection, sinusitis, infectious rhinitis (with symptoms such as sore throat, fever, thick purulent rhinorrhoea), or ocular infection. Have a history of nasal obstruction attributable to structural causes (e.g., nasal polyps, septal deviation, cleft palate, nasal surgery or other otorhinolaryngologic deformities). Have symptoms of a clinically relevant illness, in the Investigator’s opinion, within 6 weeks prior to Screening Visit. | |
E.5 End points |
E.5.1 | Primary end point(s) | Efficacy of ME3301 vs placebo in subjects with seasonal allergic rhinitis (SAR) exposed to allergen for 6 hours in the Vienna Challenge Chamber, commencing 30 minutes after dosing on day 8. | |
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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |