The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Hospital Vega Baja
Orihuela, Alicante, Spain
RECRUITINGHospital General de Granollers
Granollers, Barcelona, Spain
The combined nasal symptom and medication score
The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3.Final score range from 0 to 6, higher score meaning a worse outcome.
Time frame: 12 months of treatment
Score of the nasal symptoms scale
Symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). Final score range from 0 to 3, higher score meaning worse outcome.
Time frame: 12 months of treatment
Score of the specific medication scale
The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. Final score range from 0 to 3, higher score meaning worse outcome.
Time frame: 12 months of treatment.
Percentage of days without symptoms or medication
Percentage of days with a zero value for symptom and medication recorded in the patient digital diary
Time frame: 12 months of treatment
VAS score (completed by the patient and the investigator)
Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy
Time frame: 12 months of treatment.
RCAT questionnaire
Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control)
Time frame: 12 months of treatment.
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Hospital de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
WITHDRAWNHospital de la Plana
Castellon, Castellón, Spain
RECRUITINGHospital Regional de Málaga
Málaga, Málaga, Spain
RECRUITINGComplejo Hospitalario de Navarra
Pamplona, Navarre, Spain
RECRUITINGFundacion Sanitaria Sant Pere Claver
Barcelona, Spain
RECRUITINGHospital de Bellvitge
Barcelona, Spain
RECRUITINGHospital Germans Trias i Pujol
Barcelona, Spain
RECRUITINGHospital infantil Vall d Hebron
Barcelona, Spain
RECRUITING...and 8 more locations
Mini-RQLQ questionnaires
Mini-Rhinoconjunctivitis Quality of Life Questionnaire
Time frame: 12 months of treatment.
Values in serum of specific IgE and IgG4
Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2
Time frame: 12 months of treatment.
Number of local and systemic reactions.
Number of local and systemic reaccions associated with the treatment
Time frame: 13 months of study follow up
Cost-effectiveness analysis
Number days/ visits related to allergy
Time frame: 13 months of study follow up
The combined asthma symptom and medication score
The symptoms assessed are: symptoms during the day, symptoms during the night and physical activity limitations (all rated from 0-3). The medication score is 1 for inhalated corticoids (low dose) , 2 for inhalated corticosteroids associated with LABA, and 3 for inhalated corticosteroids medium dosis associated with LABA. The scores from the symptoms are added and divided by 3 to a total daily symptom score from 0-3. The total daily medication score ranges from 0-3.
Time frame: 12 months of treatment
PEF
Peak expiratory flow measured with a Smart Peak Flow device
Time frame: 12 months of treatment
ACT questionnaire
Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients
Time frame: 12 months of treatment