Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis
NCT ID: NCT04874714
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
18 participants
INTERVENTIONAL
2021-04-30
2023-10-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
Study Groups
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MM09-MG01(30.000-30.000)
30,000 AU/mL of MM09 and 30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months
MM09-MG01(30.000-30.000)
Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL and grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
MG01(30.000)
30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months
MG01(30.000)
Grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
MM09(30.000)
30,000 AU/mL of MM09 of subcutaneous immunotherapy once a month for 11 months
MM09(30.000)
Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Interventions
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MM09-MG01(30.000-30.000)
Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL and grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
MG01(30.000)
Grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
MM09(30.000)
Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
Placebo subcutaneous
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Eligibility Criteria
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Inclusion Criteria
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.
8. Subjects aged between 12 and 65 years, inclusive.
9. Subjects capable of complying with the dosing regimen.
10. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial.
11. Women of childbearing potential should commit to using an adequate 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.
12. Subjects who have a smartphone to record symptoms and medication.
Exclusion Criteria
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.
11. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies.
12. Subject whose condition prevents him / her from offering cooperation and or who resents severe psychiatric disorders, according to investigator criteria.
13. Subjects with known allergies to other investigational product components other than grass pollen or mites.
14. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
15. Pregnant or lactating women.
12 Years
65 Years
ALL
No
Sponsors
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BioClever 2005 S.L.
OTHER
NTS hub S.L
UNKNOWN
Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Ana Isabel Tabar Purroy, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario de Navarra
Locations
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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
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario de Álava
Vitoria-Gasteiz, Álava, Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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2018-003715-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DMV01-SIT-015
Identifier Type: -
Identifier Source: org_study_id