Seasonal rhino-conjunctivitis due to grass pollen allergy MedDRA version: 9.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: microencapsulated grass pollen extract
Product Code: MGPE
Pharmaceutical Form: Capsule*
Other descriptive name: MGPE
Concentration unit: BAU Bioequivalent Allergy Unit(s)
Concentration t
Sponsors
Curalogic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have signed the informed consent. Have a history of two consecutive seasons of moderate to severe seasonal allergic rhinitis in the period May to July that has required repeated treatment e.g. antihistamines, leukotriene antagonists, nasal steroids and topical cromones. Have a positive skin prick test to a standardised grass pollen extract (diameter of the wheal must be the same size as the positive control or longest diameter 5mm) Have a grass specific IgE level of at least 0.7kU/L using the Phadia ImmunoCAP assay. Have a positive nasal provocation test. Will be available for clinic visits for the duration of the study. Aged 18-65 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: Are pregnant and/or breastfeeding Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk. Have medical conditions in which the administration of adrenaline is contraindicated (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension) Have chronic infections Have moderate to severe perennial or structurally related rhinitis, including vasomotor rhinitis. Have a routine sleeping pattern between the hours of 6.00am to 6.00pm (i.e. night workers). Are currently receiving immunotherapy to any allergens and/or have received grass immunotherapy within 3 years of the Screening Visit. Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced FEV1<70% of the predicted value despite treatment with asthma medication. Have moderate to severe persistent asthma (GINA criteria III and IV). Will travel outside a grass pollen region during the grass pollen season (May 1-July 15) for more than 3 consecutive days or for more than a total of 7 days. Have been legally institutionalized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of orally administered MGPE compared with placebo when dosing is initiated at least 8 weeks prior to and continuing throughout the grass pollen season in grass allergic subjects.;Secondary Objective: To evaluate the treatment effect of MGPE on: average daily TSS during the grass pollen season, concomitant relief medication-adjusted TSS, concomitant relief medication usage, Rhino-conjunctivitis quality of life, global allergy evaluation score, average daily nasal and non-nasal symptom scores, individual symptom scores, proportion of days with minimal symptoms and no concomitant medication used to relieve allergy symptoms and serum immunoglobulin levels of grass specific IgG, IgG4 and IgE.;Primary end point(s): The primary efficacy measure will be the average daily Total Symptom Score (TSS) of six symptoms during the 3 contiguous peak grass pollen weeks or the grass pollen season if the peak season is less than 3 weeks. | — |
Countries
Czech Republic, Denmark, France, Germany, Latvia
Outcome results
None listed