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
Qualifiers
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
Treatments tested in this trial
- 10,000 MM09
- 30,000 MM09
- Placebo subcutaneous
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Inmunotek S.L.
Lead sponsor
BioClever 2005 S.L.
Collaborator
Source ClinicalTrials.gov