Status:
UNKNOWN
Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis
Lead Sponsor:
Inmunotek S.L.
Collaborating Sponsors:
BioClever 2005 S.L.
NTS hub S.L
Conditions:
House Dust Mite Allergy
Perennial Allergic Rhinitis
Eligibility:
All Genders
12-60 years
Phase:
PHASE3
Brief Summary
Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in pa...
Detailed Description
Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the...
Eligibility Criteria
Inclusion
- Signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 60 years, both included.
- Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
- Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
- Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
- Women of childbearing age must commit to using an adequate contraception method.
- Capable of complying with dosage regimen.
- Owning a smartphone to register symptoms and medication consumption.
- A negative skin prick test to other aeroallergens with specific IgE \< 3.5 kU/L with no clinical relevance.
Exclusion
- Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
- Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
- Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- Uncontrolled or severe asthma and/or FEV1 \<70% despite pharmacological treatment by the time of enrolment.
- Intake of β-blockers.
- Use of immunosuppressive or biological drug.
- Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
- Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
- Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
- Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
- Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
- Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
- Known allergy to any of the ingredients of the study medication except for mites.
- Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
- Breast-feeding or pregnant women.
- Being immediate family of the investigator.
- Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
- History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05400811
Start Date
December 1 2022
End Date
July 1 2025
Last Update
November 18 2022
Active Locations (16)
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1
Hospital Universitario de Elche
Elche, Alicante, Spain, 03203
2
Policlínica Nuestra Sra del Rosario
Ibiza Town, Balearic Islands, Spain, 07800
3
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
4
Hospital de Terrassa
Terrassa, Barcelona, Spain, 08227