Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
NCT ID: NCT04891237
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2021-06-14
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
Study Groups
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10,000 MG01 + 10,000 T517
10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
10,000 MG01 + 10,000 T517
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
30,000 MG01 + 10,000 T517
30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
30,000 MG01 + 10,000 T517
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Placebo
The same solution and presentation as the active treatment, but without active ingredients
Interventions
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10,000 MG01 + 10,000 T517
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
30,000 MG01 + 10,000 T517
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Placebo
The same solution and presentation as the active treatment, but without active ingredients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects of both sexes aged between 12 and 65 years.
3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value \> 3,5 KU / L.
6. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
7. Women of childbearing potential, and men participating in the trial, should commit to using an appropriate 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.
8. Subjects capable of complying with the dosage regimen.
9. Subjects who have a smartphone to record symptoms and medication.
10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology
11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology
Exclusion Criteria
2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
4. Subjects in which 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.
5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
6. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
7. Subjects under treatment with ß-blockers.
8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, 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, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
13. Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
14. Subjects with a known allergy to other investigational drug components other than the allergen.
15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
16. Subjects who are direct relatives of the researchers.
17. Pregnant or lactating women.
12 Years
65 Years
ALL
No
Sponsors
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Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Irán Sánchez
Role: STUDY_CHAIR
Private Site
Locations
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Cedt de Tarancón
Tarancón, Cuenca, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Centro Médico Iza
Tres Cantos, Madrid, Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain
Private Practice
Albacete, , Spain
Hospital Ntra. Sra. de Sonsoles
Ávila, , Spain
Clinica Dermatologica Y Alergia
Badajoz, , Spain
Hospital Quironsalud Clideba
Badajoz, , Spain
Hospital Universitario Dexeus
Barcelona, , Spain
Clínica privada Barcelona
Barcelona, , Spain
Hospital General Universitario Ciudad Real
Ciudad Real, , Spain
Hospital Quironsalud Córdoba
Córdoba, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Universitario de Jaén
Jaén, , Spain
Hospital Universitari Santa María
Lleida, , Spain
Private practice
Madrid, , Spain
Hospital Universitario Cruz Roja
Madrid, , Spain
Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
Madrid, , Spain
Clínica Subiza
Madrid, , Spain
Hospital Carlos Iii
Madrid, , Spain
Hospital Universitario Rey Juan Carlos
Madrid, , Spain
Hospital Quirónsalud Málaga
Málaga, , Spain
Private Practice
Málaga, , Spain
Private Practice
Murcia, , Spain
Private Practice
Palencia, , Spain
Hospital Universitario Infanta Cristina
Parla, , Spain
Clínica privada Sevilla
Seville, , Spain
Hospital Virgen Del Rocío
Seville, , Spain
Hospital Viamed Santa Ángela de La Cruz
Seville, , Spain
Private Practice
Toledo, , Spain
Hospital Recoletas Felipe Ii
Valladolid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Diana Pérez Alzate
Role: primary
References
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Subiza J, Feliu A, Subiza JL, Uhlig J, Fernandez-Caldas E. Cluster immunotherapy with a glutaraldehyde-modified mixture of grasses results in an improvement in specific nasal provocation tests in less than 2.5 months of treatment. Clin Exp Allergy. 2008 Jun;38(6):987-94. doi: 10.1111/j.1365-2222.2008.02995.x. Epub 2008 Apr 25.
Klimek L, Uhlig J, Mosges R, Rettig K, Pfaar O. A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol. Allergy. 2014 Dec;69(12):1629-38. doi: 10.1111/all.12513. Epub 2014 Oct 6.
Guzman-Fulgencio M, Caballero R, Lara B, Mena M, Tejera M, Sastre A, Subiza JL, Fernandez-Caldas E, Casanovas M. Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):198-207. doi: 10.1016/j.aller.2016.08.008. Epub 2016 Dec 7.
Other Identifiers
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DMV03-SIT-027
Identifier Type: -
Identifier Source: org_study_id
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