Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891237
• Other study ID #: DMV03-SIT-027
• Status: Recruiting
• Phase: Phase 3
• Start date: June 14, 2021
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Inmunotek S.L.
• Contact: Miguel Casanovas
• Phone: 912908942
• Email: mcasanovas[@]inmunotek.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Allergic
• Rhinitis
• Rhinitis, Allergic
• Rhinoconjunctivitis

Intervention

Biological:
• 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

Other:
• Placebo
The same solution and presentation as the active treatment, but without active ingredients

Locations

Country	Name	City	State
Spain	Private Practice	Albacete
Spain	Hospital Universitario Principe de Asturias	Alcalá De Henares	Comunidad De Madrid
Spain	Clinica Dermatologica Y Alergia	Badajoz
Spain	Hospital Universitario Dexeus	Barcelona
Spain	Hospital Quironsalud Córdoba	Córdoba
Spain	Hospital Clínico Universitario Virgen de Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital Universitari Santa María	Lleida
Spain	Cap José Marvá	Madrid
Spain	Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA	Madrid
Spain	Clínica Subiza	Madrid
Spain	Hospital Universitario Cruz Roja	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Madrid
Spain	Private practice	Madrid
Spain	Hospital Quirónsalud Málaga	Málaga
Spain	Private Practice	Málaga
Spain	Private Practice	Murcia
Spain	Private Practice	Palencia
Spain	Hospital Viamed Santa Ángela de La Cruz	Sevilla
Spain	Hospital Virgen Del Rocío	Sevilla
Spain	Cedt de Tarancón	Tarancon	Cuenca
Spain	Private Practice	Toledo
Spain	Centro Médico Iza	Tres Cantos	Madrid
Spain	Hospital Infanta Elena	Valdemoro	Madrid
Spain	Hospital Recoletas Felipe Ii	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication-free days	Number of days that the subjects need no medication	12 months
Secondary	Symptom-free days	Number of days that the subjects have no symptom	12 months
Secondary	Asthmatic exacerbations	Time elapsed until the first appearance of asthmatic exacerbations	12 months
Secondary	Visual Analogue Scale (VAS)	Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side very bad and right side very well	12 months
Secondary	Quality of life rhinitis test	Quality of life rhinitis test (ESPRINT-15)	12 months
Secondary	Quality of life asthma test	Control of asthma by Asthma Control Quality questionnaire	12 months
Secondary	Health resources	For each patient, the number of times that due to allergy symptoms has done the following will be counted: Have visited the GP, Have made an unscheduled visit to the specialist, Has gone to the emergency room, Has been hospitalized, Have needed to contact the doctor by phone	12 months
Secondary	Immunological parameters	Analyses of total and specific IgE, specific Ig G4	12 months
Secondary	Security parameters	Global rate and severity of AE per administration and per subject	12 months
Secondary	Adverse Reactions	Local and systemic reactions and any medication administered for the treatment of AR	12 months