Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen
1 other identifier
interventional
180
1 country
32
Brief Summary
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2021
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedMay 7, 2025
May 1, 2025
4.6 years
April 30, 2021
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSMS: Combined Symptoms and Medication Score
Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day
12 months
Secondary Outcomes (10)
Medication-free days
12 months
Symptom-free days
12 months
Asthmatic exacerbations
12 months
Visual Analogue Scale (VAS)
12 months
Quality of life rhinitis test
12 months
- +5 more secondary outcomes
Study Arms (3)
10,000 MG01 + 10,000 T517
EXPERIMENTAL10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
30,000 MG01 + 10,000 T517
EXPERIMENTAL30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Placebo subcutaneous
PLACEBO COMPARATORThe same solution and presentation as the active treatment, but without active ingredients.
Interventions
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
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
The same solution and presentation as the active treatment, but without active ingredients
Eligibility Criteria
You may qualify if:
- Subject who has signed the informed consent.
- Subjects of both sexes aged between 12 and 65 years.
- 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
- 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.
- 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.
- Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
- 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.
- Subjects capable of complying with the dosage regimen.
- Subjects who have a smartphone to record symptoms and medication.
- 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
- 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
You may not qualify if:
- Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
- Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
- Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
- 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.
- Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- Subjects under treatment with ß-blockers.
- Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
- 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.
- Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
- 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,).
- Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
- Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
- Subjects with a known allergy to other investigational drug components other than the allergen.
- Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- Subjects who are direct relatives of the researchers.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmunotek S.L.lead
Study Sites (32)
Cedt de Tarancón
Tarancón, Cuenca, 16400, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Centro Médico Iza
Tres Cantos, Madrid, 28760, Spain
Hospital Infanta Elena
Valdemoro, Madrid, 28342, Spain
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, 30120, Spain
Private Practice
Albacete, 02003, Spain
Hospital Ntra. Sra. de Sonsoles
Ávila, 05004, Spain
Clinica Dermatologica Y Alergia
Badajoz, 06001, Spain
Hospital Quironsalud Clideba
Badajoz, 06011, Spain
Hospital Universitario Dexeus
Barcelona, 08028, Spain
Clínica privada Barcelona
Barcelona, 08172, Spain
Hospital General Universitario Ciudad Real
Ciudad Real, 13005, Spain
Hospital Quironsalud Córdoba
Córdoba, 14004, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016, Spain
Hospital Universitario de Jaén
Jaén, 23007, Spain
Hospital Universitari Santa María
Lleida, 25198, Spain
Private practice
Madrid, 28001, Spain
Hospital Universitario Cruz Roja
Madrid, 28003, Spain
Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
Madrid, 28006, Spain
Clínica Subiza
Madrid, 28006, Spain
Hospital Carlos Iii
Madrid, 28029, Spain
Hospital Universitario Rey Juan Carlos
Madrid, 28933, Spain
Hospital Quirónsalud Málaga
Málaga, 29004, Spain
Private Practice
Málaga, Spain
Private Practice
Murcia, Spain
Private Practice
Palencia, 34001, Spain
Hospital Universitario Infanta Cristina
Parla, 28981, Spain
Clínica privada Sevilla
Seville, 41005, Spain
Hospital Virgen Del Rocío
Seville, 41013, Spain
Hospital Viamed Santa Ángela de La Cruz
Seville, 41014, Spain
Private Practice
Toledo, 45005, Spain
Hospital Recoletas Felipe Ii
Valladolid, 47003, Spain
Related Publications (3)
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.
PMID: 18445082BACKGROUNDKlimek 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.
PMID: 25130503BACKGROUNDGuzman-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.
PMID: 27939406BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Irán Sánchez
Private Site
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 18, 2021
Study Start
June 14, 2021
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
May 7, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share