Table 2 Criteria for a recommendable product for SIT
From: Allergen immunotherapy on the way to product-based evaluation—a WAO statement
Minimum expectations for a SIT product to be used in adults: |
At least one successful state-of-the-art DBPCR trial in adults for the first year of treatment, best preceded by a dose–response study (nasal provocation testing or allergen exposure chambers may be used for the dose finding) |
Additional claims can be justified as follows: |
Claims on sustained effects of a product should be based on a successful DBPCR study, based on appropriate sample size calculation, over 3 years of treatment |
Claims on disease modifying effects: such studies need be followed up blindly for at least two consecutive years without treatment while maintaining monitoring symptoms |
Claims for efficacy in asthmatics should be based on an appropriate successful DBPCR study in the appropriate patient group. For claims on tolerability in asthmatics only, the study can also be performed in allergic rhinitis subjects with comorbid asthma. |
Minimum expectations for a SIT product to be used in children: |
At least one state-of-the-art DBPCR confirmatory trial in children for the first year of treatment |
Additional claims can be justified as follows: |
Claims on sustained effects of a product should be based on a successful DBPCR study, based on appropriate sample size calculation, over 3 years of treatment |
Claims on disease modifying effects: such studies have to be followed up at least two consecutive years without treatment while maintaining monitoring symptoms |