Allergic rhinitis/rhinoconjunctivitis caused by dust mite allergy
Conditions
Brief summary
The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a rhinomanometer provided by the sponsor, and the response will be considered positive if the NIPF decreases by ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptom scores on a 13-point scale.
Detailed description
Assessment of rescue medication use throughout the study in relation to the investigational product/placebo., Evaluation of adverse reactions occurring during the patient follow-up period specified in the study., Analytical determinations of serum markers (specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, Der p1 and Der p2; and IgG4 to Dermatophagoides) at baseline and at the end of the study., Assessment of the primary wheal resulting from skin prick tests with Dermatophagoides pteronyssinus and Dermatophagoides farinae at baseline and at the end of the study: the primary wheal will be calculated as the mean of the two diameters ([largest diameter + smallest diameter] / 2). Subsequently, the group mean will be calculated based on the results of each enrolled subject, to allow for comparative analysis between groups., Evaluation of all individual variables from the scoring scale used in the nasal provocation test.
Interventions
DRUGVacuna Dermatophagoides mezcla 1000 TBU/ml
DRUGVacuna Dermatophagoides mezcla 6000 TBU/ml
DRUGVacuna Dermatophagoides mezcla Placebo
DRUGVacuna Dermatophagoides mezcla 3000 TBU/ml
DRUGTest de provocación nasal
Sponsors
Asac Pharmaceutical Inmunology S.A., Advanced Outcomes Research S.L.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a rhinomanometer provided by the sponsor, and the response will be considered positive if the NIPF decreases by ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptom scores on a 13-point scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of rescue medication use throughout the study in relation to the investigational product/placebo., Evaluation of adverse reactions occurring during the patient follow-up period specified in the study., Analytical determinations of serum markers (specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, Der p1 and Der p2; and IgG4 to Dermatophagoides) at baseline and at the end of the study., Assessment of the primary wheal resulting from skin prick tests with Dermatophagoides pteronyssinus and Dermatophagoides farinae at baseline and at the end of the study: the primary wheal will be calculated as the mean of the two diameters ([largest diameter + smallest diameter] / 2). Subsequently, the group mean will be calculated based on the results of each enrolled subject, to allow for comparative analysis between groups., Evaluation of all individual variables from the scoring scale used in the nasal provocation test. | — |
Countries
Spain
Outcome results
None listed