Clinical trial NCT04891237: Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rhinitis, Allergic
Rhinoconjunctivitis
Asthma, Allergic
Keywords: Rhinitis/ Rhinoconjunctivitis
Mild to moderate asthma
Allergy
Grasses
Olea
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group study
Primary purpose: TREATMENT

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

Detailed description: Double blind, multicenter, parallel, placebo controlled study. It includes 180 subjects sensitised to olea and grass pollen with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma, from 12 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

Eligibility criteria: Inclusion Criteria:

1. Subject who has signed the informed consent.
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:

1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
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.

Primary outcomes:
measure: CSMS: Combined Symptoms and Medication Score
timeFrame: 12 months
Secondary outcomes:
measure: Medication-free days
timeFrame: 12 months
measure: Symptom-free days
timeFrame: 12 months
measure: Asthmatic exacerbations
timeFrame: 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: 12 months
measure: Quality of life rhinitis test
timeFrame: 12 months
measure: Quality of life asthma test
timeFrame: 12 months
measure: Health resources
timeFrame: 12 months
measure: Immunological parameters
timeFrame: 12 months
measure: Security parameters
timeFrame: 12 months
measure: Adverse Reactions
timeFrame: 12 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Comunidad De Madrid
city: Tarancon
country: Spain
facility: Cedt de Tarancón
state: Cuenca
city: Tres Cantos
country: Spain
facility: Centro Médico Iza
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Infanta Elena
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de Arrixaca
state: Murcia
city: Albacete
country: Spain
facility: Private Practice
city: Badajoz
country: Spain
facility: Clinica Dermatologica Y Alergia
city: Badajoz
country: Spain
facility: Hospital Quironsalud Clideba
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus
city: Barcelona
country: Spain
facility: Clínica privada Barcelona
city: Ciudad Real
country: Spain
facility: Hospital General Universitario Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Quironsalud Córdoba
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Lleida
country: Spain
facility: Hospital Universitari Santa María
city: Madrid
country: Spain
facility: Private practice
city: Madrid
country: Spain
facility: Hospital Universitario Cruz Roja
city: Madrid
country: Spain
facility: Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
city: Madrid
country: Spain
facility: Clínica Subiza
city: Madrid
country: Spain
facility: Hospital Carlos Iii
city: Madrid
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Murcia
country: Spain
facility: Private Practice
city: Málaga
country: Spain
facility: Hospital Quirónsalud Málaga
city: Málaga
country: Spain
facility: Private Practice
city: Palencia
country: Spain
facility: Private Practice
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Sevilla
country: Spain
facility: Clínica privada Sevilla
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocío
city: Sevilla
country: Spain
facility: Hospital Viamed Santa Ángela de La Cruz
city: Toledo
country: Spain
facility: Private Practice
city: Valladolid
country: Spain
facility: Hospital Recoletas Felipe Ii
city: Ávila
country: Spain
facility: Hospital Ntra. Sra. de Sonsoles
Study officials:
affiliation: Private Site
name: Irán Sánchez
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.