Efficacy and Safety Evaluation for the Treatment of asthma and allergic rhinitis/rhinoconjunctivitis
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870Mild to moderate asthma and allergic rhinitis / rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen.MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 21.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870
- Registration Number
- EUCTR2018-003715-22-ES
- Lead Sponsor
- Inmunotek, S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
1. Subjects who have signed the informed consent
2. Subjects with a confirmed medical history of asthma (intermittent or persistent mild-moderate, controlled), as defined by GEMA 5 with rhinitis / rhinoconjunctivitis (intermittent or persistent) according to the ARIA classification caused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D. farinae).
3. Subjects with a positive prick test (average diameter of the papule = to 5 mm) to a standardized extract of grass pollen mixture, or to one of the components of the mixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleum pratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D. farinae, tested within the 12 months prior to signing the informed consent.
4. Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value = 3 KU / L, tested within the 12 months prior to signing the informed consent.
5. Subjects aged between 18 and 65 years.
6. Subjects capable of complying with the dosing regimen.
7. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial.
8. Women of childbearing potential and men participating in the trial should commit to using an adequate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.
9. Subjects who have a smartphone to record symptoms and medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Subjects who have received prior immunotherapy treatment in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
2. Subjects sensitized to other aeroallergens other than grass or mites pollen belonging to the genus Dermatophagoides, with the exception of epithelia as long as the subject has occasional exposure and symptoms.
3. Patients in whom immunotherapy may be the object of 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 cannot be included.
4. Subjects with uncontrolled severe asthma, and / or with a FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial.
5. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
6. Subjects under treatment with ß-blockers.
7. Subjects under treatment with immunosuppressive or biological drugs.
8. Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.).
9. Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema.
10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, diabetes, malformations, subjects who underwent multiple surgeries, kidney disease...), according to investigator’s criteria.
12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies.
13. Subject whose condition prevents him / her from offering cooperation and or who presents severe psychiatric disorders, according to investigator criteria.
14. Subjects with known allergies to other investigational product components other than grass pollen or mites.
15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
16. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method