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Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Prospective, Randomized, Placebo-controlled, Multi-center Trial Comparing the Efficacy and Safety of Subcutaneous Immunotherapy With a Mixture of Grasses and Mites at Adequate Doses Versus Monotherapy, for the Treatment of Allergy

NCT04874714•Inmunotek S.L.

View on ClinicalTrials.gov

Summary

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and allergic rhinitis/rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen

Detailed Description

Double blind, parallel placebo-controlled study. The subjects will receive medication during 11 months

Eligibility

Age

12 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who have signed the informed consent
•2. Subjects with a confirmed medical history of asthma (intermittent or persistent mild-moderate, controlled), as defined by GEMA 5 with moderate-severe rhinitis / rhinoconjunctivitis (intermittent or persistent) according to the ARIA classification caused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D. farinae). The diagnosis of asthma will be valid from 24 months prior to signing the informed consent.
•3. Subjects with a positive prick test (major diameter of the papule ≥ to 5 mm) to a standardized extract of grass pollen mixture, or to one of the components of the mixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleum pratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D. farinae. Results will be valid 12 months prior to signing the informed consent.
•4. Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense or a mixture of grasses and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value \> 3,5 KU / L. Results will be valid 12 months prior to signing the informed consent.
•5. Subjects will preferably be sensitive to study allergens (Dermatophagoides and grasses). In the case of subjects sensitized to other aeroallergens, only those with the following characteristics (results valid up to 12 months prior to signing of the informed consent) can be included in the study:
•1. Subjects with a positive prick test for Blomia tropicalis and Lepidoglyphus destructor, whose maximum values of specific IgE are 3.5 KU/L and do not exceed or equal the values of the allergens of the study (Dermatophagoides and grasses).
•2. Subjects with a negative prick test to epithelium, whose specific IgE values are \< 0.35 KU/L. Subjects with occasional exposure and symptomatology to epithelium may be included with a positive prick test regardless of the value of the specific IgE.
•3. Subjects with a positive prick test for non-coestational pollens, whose maximum values of specific IgE are 17.5 KU / L and do not exceed or equal the values of the allergens of the study (Dermathophagoids and grasses) and who also do not present exacerbations in the pollen season.
•6. Subjects with a negative prick test for fungi. If the specific IgE determination has been made, the result shall be \< 0,35 KU/L.
•7. Subjects with a negative prick test for coestacional pollens with grasses. If the specific IgE determination has been made, the result shall be \< 0,35 KU/L.
+5 more criteria

Exclusion Criteria

•1. Subjects who have received prior immunotherapy treatment in the preceding 5 years for any aeroallergen.
•2. Patients in whom immunotherapy may be the object of 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 cannot be included.
•3. Subjects with severe or uncontrolled asthma, and / or with a FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial.
•4. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
•5. Subjects under treatment with ß-blockers.
•6. Subjects under treatment with immunosuppressive or biological drugs.
•7. Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.).
•8. Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema.
•9. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
•10. 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, diabetes, malformations, subjects who underwent multiple surgeries, kidney disease...), according to investigator's criteria.
+5 more criteria

Locations (13)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Santa Bárbara

Puertollano, Ciudad Real, Spain

Hospital el Bierzo

Ponferrada, León, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario A Coruña

A Coruña, Spain

Centro Médico ASISA Dr. Lobatón

Cadiz, Spain

C.P.E. Virgen de la Cinta - Hospital Universitario Juan Ramón Jiménez

Huelva, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital Quirón Salud Málaga

Málaga, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Key Dates

Start Date

April 30, 2021

Primary Completion Date

October 9, 2023

Completion Date

October 9, 2023

Last Updated

December 19, 2023

Enrollment

ACTUAL participants

Conditions

Allergic RhinoconjunctivitisPerennial Allergic RhinitisHouse Dust Mite AllergyPollen Allergy

Interventions

MM09-MG01(30.000-30.000)

BIOLOGICAL

MG01(30.000)

BIOLOGICAL

MM09(30.000)

BIOLOGICAL

Placebo subcutaneous

BIOLOGICAL

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

NCT06778213

Allergic Rhinoconjunctivitis

View study

ACTIVE_NOT_RECRUITINGPHASE3

A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite (HDM)

NCT06920771

House Dust Mite AllergyHouse Dust Mite Rhinitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Inclusion Criteria

Exclusion Criteria

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite (HDM)

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