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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04898283
Other study ID # DMV02-SIT-026
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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