A randomised, double-blind, placebo-controlled crossover study to investigate the efficacy and safety of three doses of ME3301 in patients with seasonal allergic rhinitis during allergen challenge in the Vienna Challenge Chamber

Conditions: seasonal allergic rhinitis

Registration Number: EUCTR2004-000684-10-AT

Lead Sponsor: Meiji Seika Kaisha, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.