Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

Rhinoconjunctivitis Clinical Trial

Official title:

A RDPC, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of SCIT in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to Cupressaceae and Grasses.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898283
• Other study ID #: DMV02-SIT-026
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2021
• Est. completion date: April 2024

Study information

• Verified date: November 2022
• Source: Inmunotek S.L.
• Contact: Pedro Carretero, MD
• Phone: 947 28 18 00
• Email: pcarreteroa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Description:

Double blind, multicenter, parallel, placebo controlled study. It includes 150 subjects sensitised to cupressaceae and grass pollen, from 14 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Written informed consent.

2. Aged between 12 and 65, both genders

3. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen.

4. Subjects with a positive skin prick-test (wheal size >5 mm diameter) to a standardized grass pollen extract (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to a one extract of the mixture and to a cupressaceae extract.

5. Specific IgE = 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite).

6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.

7. Women of childbearing potential 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 dosing regimen.

9. Subjects who own a smartphone for symptom registration 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 with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms.

2. Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses.

3. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.

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 intermittent or 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 had a severe secondary reaction during the prick test diagnostic skin test.

7. Subjects treated with beta-blockers.

8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).

9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, 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 adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).

11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,).

12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.

13. Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders.

14. Subjects with a known allergy to components of the investigational medicinal product other than the allergen.

15. Subjects with lower respiratory diseases 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 T521
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 cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
• 30,000 MG01 +10,000 T521
Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Principe de Asturias	Alcalá De Henares	Comunidad De Madrid
Spain	Hospital U. Fundación Alcorcón	Alcorcón	Madrid
Spain	Fundación Hospital Sant Pere Claver	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Clinica privada	León
Spain	CAP José Marva	Madrid
Spain	Clínica Ojeda	Madrid	Comunidad De Madrid
Spain	Clínica Privada	Madrid
Spain	Clínica Subiza	Madrid
Spain	Hospital Cruz Roja Madrid	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Comunidad De Madrid
Spain	Clínica Privada Murcia	Murcia	Región De Murcia
Spain	Clinica privada	Palencia
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Clinica Privada Soria	Soria
Spain	Cedt de Tarancon	Tarancon	Cuenca
Spain	Hospital Recoletas Felipe Ii	Valladolid	Castilla Y León
Spain	Clínica Privada Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSMS: Combined Symptoms and Medication Score, asthma and rhinitis.	Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.	12 months
Secondary	Medication free days	Both rhinitis/rhinoconjunctivitis and asthma	12 months
Secondary	Symptom free days	Both rhinitis/rhinoconjunctivitis and asthma	12 months
Secondary	Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026	Comparison between the beginning and end of the trial and among active groups and placebo	12 months
Secondary	Quality of life associated with asthma	The quality of life associated with asthma will be measured following the ACQ questionnaire.; The ACQ questionnaire consists of 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from 0 = fully controlled to 6 = extremely poorly controlled). The questionnaire score is the mean of the 6 responses (ACQ-6).; The interpretation of the scores is as follows: Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control	12 months
Secondary	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 (0) = very bad and right side (10) = very well	12 months
Secondary	Asthmatic exacerbations	Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.	12 months
Secondary	Health resource consumption	Counting the Health resource consumption: visits to specialists, telephone calls, test and analyses.	12 months
Secondary	Quality of life associated with rhinitis	The quality of life associated with rhinitis will be measured following the test ESPRINT-15.; The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items).; The interpretation of the scores is between 0 (low impact) and 6 (high impact).	12 months