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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02661854 |
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Date of registration:
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20/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy
MM09 |
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Scientific title:
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Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against a Mixture of Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract |
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Date of first enrolment:
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June 21, 2016 |
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Target sample size:
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186 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02661854 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Antonio de Mateo, PhD; MD |
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Name:
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Isabel Flores, PhD; MD |
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Name:
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Mónica Antón, PhD; MD |
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Name:
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Pilar Alba, PhD; MD |
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Name:
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Javier Fernández, PhD; MD |
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Name:
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Carmen Pérez, PhD; MD |
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Name:
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Javier Montoro, PhD; MD |
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Name:
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Ángel Ferrer |
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Name:
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Antonio Nieto, PhD; MD |
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Name:
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David El-Qutob, PhD; MD |
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Name:
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Carmen Andreu, PhD; MD |
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Name:
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Vicente Jover, PhD; MD |
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Name:
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Luis Angel Navarro, PhD; MD |
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Name:
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Mª Dolores Hernández, PhD; MD |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe
rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to
Dermatophagoides pteronyssinus and/or Dermatophagoides farinae allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter)
- Specific immunoglobulin E against house dust mites >10 kU/L and whose determination
does not exceed 6 months prior to the inclusion visit
- Age between 12 and 65 years
- Both genders
- Subjects capable of giving informed consent
- Subjects capable of complying with the dosing regimen
- Subjects that have not received immunotherapy in the last 5 years
- Subjects presenting sensitization to another aeroallergens, but that is considered
clinically not relevant or no clinical interference with the nasal provocation test.
Exclusion Criteria:
- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic
rhinitis/rhinoconjunctivitis due to mites and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute contraindication according to the
criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical
Immunology, and of the European Allergy and Clinical Immunology Immunotherapy
Subcommittee may also include.
- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the
suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma , with a forced expiratory
volume (FEV) < 70 respect to the reference value in spite of the appropriate
pharmacological treatment at the time of the inclusion in the trial.
- Subjects that have required oral corticosteroids in the 12 weeks previous to the
inclusion in the trial.
- Subjects that have previously submitted a serious secondary reaction during the skin
prick test
- Subjects in treatment with beta blockers.
- Unstable subjects from the clinical point of view (respiratory infection, febrile,
acute urticaria, etc.) at the time of the inclusion in the clinical trial
- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
- Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.)
is contraindicated.
- Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis,
but of potential severity and that could interfere with treatment and follow-up
(epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney
diseases,...).
- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis
of immunodeficiency diseases.
- Subject whose status prevents him from providing cooperation and or which present
severe psychiatric disorders.
- Subject with known allergy to other components of the vaccine different from mites
allergen extract.
- Subjects with lower airway diseases other than asthma such as emphysema or
bronchiectasis.
- Direct investigator's relatives.
- Pregnant or women at risk of pregnancy and breastfeeding women.
Age minimum:
12 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rhinitis
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Rhinoconjunctivitis
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Intervention(s)
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Biological: MM09 Mannosylated 5.000 sublingual
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Biological: MM09 Mannosylated 10.000 subcutaneous
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Biological: MM09 Mannosylated 10.000 sublingual
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Biological: MM09 Mannosylated 5.000 subcutaneous
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Biological: MM09 Mannosylated 50.000 sublingual
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Biological: MM09 Mannosylated 50.000 subcutaneous
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Biological: Subcutaneous placebo
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Biological: MM09 Mannosylated 30.000 subcutaneous
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Biological: MM09 Mannosylated 30.000 sublingual
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Biological: Sublingual placebo
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Primary Outcome(s)
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Concentration required to elicit a positive response after nasal provocation test (NPT)
[Time Frame: 4 months]
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Secondary Outcome(s)
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Dose finding skin prick test
[Time Frame: 4 months]
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Number of participants with treatment-related adverse events as assessed by MM09-SIT-013
[Time Frame: 4 months]
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Secondary ID(s)
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2015-000820-27
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MM09-SIT-013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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