Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorInmunotek S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent.
Age between 12 and 65, both genders.
Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
Subjects with a positive skin prick-test wheal size >5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.
Disqualifiers
Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
Subjects in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
Subjects with persistent severe or uncontrolled asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
Trial design
Design model
Parallel
Treatments tested in this trial
10,000 MM09
Biological/VaccinePurified 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
30,000 MM09
Biological/VaccinePurified 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
Placebo subcutaneous
Biological/VaccineThe same solution and presentation as the active treatment, but without active ingredients.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Experimental:10,000 MM09Experimental treatment 1 intervention
Group B: Experimental: 30,000 MM09Experimental treatment 1 intervention
Group C: Placebo subcutaneousPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Medication-free days
Number of days that the subjects need no medication
Time frame
12 months2
Symptom-free days
Number of days that the subjects have no symptom
Time frame
12 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Inmunotek S.L.
Lead sponsor
BioClever 2005 S.L.
Collaborator
Source ClinicalTrials.gov