A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
The same solution and presentation as the active treatment, but without active ingredients.
CSMS: Combined Symptoms and Medication Score
Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.
Time frame: 12 months
Medication-free days
Number of days that the subjects need no medication
Time frame: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-023
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 12 months
Quality of life associated with asthma
The quality of life associated with asthma will be measured following the GINA questionnaire. The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO. The interpretation of the answers is as follows: Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES
Time frame: 12 months
Quality of life associated with rhinitis
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).
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Hospital Provincial de Conxo
Santiago de Compostela, A Coruña, Spain
RECRUITINGIMED Elche
Elche, Alicante, Spain
RECRUITINGHospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
RECRUITINGClinica Tecma
Valencia, Alzira, Spain
COMPLETEDClinica Virgen del Rosario
Algeciras, Cadiz, Spain
ACTIVE_NOT_RECRUITINGHospital HLA Jerez Puerta Sur
Jerez de la Frontera, Cádiz, Spain
WITHDRAWNHospital Dr. Peset
Valencia, España, Spain
RECRUITINGHospital General Universitario Santa Maria de Rosell
Cartagena, Murcia, Spain
WITHDRAWNHospital Rivera Povisa
Vigo, Pontevedra, Spain
ACTIVE_NOT_RECRUITINGHospital General Universitario Dr. Balmis
Alicante, Spain
RECRUITING...and 22 more locations
Time frame: 12 months
Visual Analogue Scale (VAS)
Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well.
Time frame: 12 months
Immunological parameters
Analyses of total IgE and specific IgA,IgG and IgG4
Time frame: 12 months