seasonal allergic rhinitis
Conditions
Interventions
Product Name: ME3301
Product Code: ME3301
Pharmaceutical Form: Film-coated tablet
CAS Number: 222633-22-9
Current Sponsor code: ME3301
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Meiji Seika Kaisha, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;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. | — |
Countries
Austria
Outcome results
None listed