Seasonal grass pollen induced allergic rhino-conjunctivitis with or without asthma. MedDRA version: 17.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: AVANZ Phleum Pratense
Product Code: AVANZ Phleum Pratense
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administrati
Sponsors
ALK-Abello A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A documented clinically relevant history of moderate-to-severe grass pollen induced rhinoconjunctivitis with or without asthma despite having received treatment with symptom relieving medication during the previous two grass pollen seasons Positive SPT response (wheal diameter = 3 mm) to Phleum pratense at screening Positive specific IgE against Phleum pratense (= IgE Class 2; =0.70 kU/L) at screening Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a TNSS of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC 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 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate, . Subjects sentised to ragweed, mugwort or Alternaria alternate are not eligible for the trial if they have symptoms induced by these allergens Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed. Subjects sensitised to perennial allergens such as house dust mites, and moulds are not eligible for the trial if they have symptoms induced by these allergens Clinical history of uncontrolled asthma within 3 months prior to screening Subjects with reduced lung function FEV1 <70% of the predicted value after adequate pharmacologic treatment Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons Previous treatment with immunotherapy to a grass pollen allergen or a cross-reacting allergen within the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of AVANZ® Phleum pratense 15000 SQ+ compared to placebo in the treatment of grass pollen-induced allergic rhinitis using a Environmental Challenge Chamber. ;Secondary Objective: To evaluate; The safety and tolerability of AVANZ® Phleum pratense 15000 SQ+ compared to placebo. Changes in immunological parameters. The efficacy of AVANZ® Phleum pratense 15000 SQ+ during treatment. ;Primary end point(s): The primary efficacy endpoint is the average Total Nasal Symptom Score (TNSS) measured after end of treatment with AVANZ compared to placebo. ;Timepoint(s) of evaluation of this end point: After approximately 11 months of treatment with AVANZ | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: During and after treatment with AVANZ.;Secondary end point(s): Changes in immunological parameters during and after treatment with AVANZ. Adverse Events during treatment with AVANZ. Average Total Nasal Symptom Score (TNSS) measured during treatment with AVANZ compared to placebo. Average Total Nasal and Eye Symptom Score measured during and after treatment with AVANZ compared to placebo. | — |
Countries
Germany
Contacts
Public ContactNadia Ghaussy
ALK-Abello Arzeimittel GmbH
Outcome results
None listed