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Trial record 56 of 248 for:    test AND provocation

Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy (MM09)

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ClinicalTrials.gov Identifier: NCT02661854
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Inmunotek S.L.

Brief Summary:
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy

Condition or disease Intervention/treatment Phase
Rhinitis Rhinoconjunctivitis Biological: MM09 Mannosylated 5.000 subcutaneous Biological: MM09 Mannosylated 10.000 subcutaneous Biological: MM09 Mannosylated 30.000 subcutaneous Biological: MM09 Mannosylated 50.000 subcutaneous Biological: MM09 Mannosylated 5.000 sublingual Biological: MM09 Mannosylated 10.000 sublingual Biological: MM09 Mannosylated 30.000 sublingual Biological: MM09 Mannosylated 50.000 sublingual Biological: Subcutaneous placebo Biological: Sublingual placebo Phase 2

Detailed Description:
Double blind placebo-controlled study. The subjects will receive medication during 4 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : June 21, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: MM09 Mannosylated 5.000 subcutaneous
5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 5.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Other Name: Manano

Biological: Sublingual placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 10.000 subcutaneous
10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 10.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological: Sublingual placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 30.000 subcutaneous
30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 30.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological: Sublingual placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 50.000 subcutaneous
50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Biological: MM09 Mannosylated 50.000 subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

Biological: Sublingual placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 5.000 sublingual
5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 5.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

Biological: Subcutaneous placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 10.000 sublingual
10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 10.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

Biological: Subcutaneous placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 30.000 sublingual
30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 30.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

Biological: Subcutaneous placebo
Comparison between placebo and active group

Experimental: MM09 Mannosylated 50.000 sublingual
50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Biological: MM09 Mannosylated 50.000 sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

Biological: Subcutaneous placebo
Comparison between placebo and active group

Placebo Comparator: Placebo Sublingual Placebo subcutaneous
Sublingual and subcutaneous placebo.
Biological: Subcutaneous placebo
Comparison between placebo and active group

Biological: Sublingual placebo
Comparison between placebo and active group




Primary Outcome Measures :
  1. Concentration required to elicit a positive response after nasal provocation test (NPT) [ Time Frame: 4 months ]

    Change in the threshold concentration of mite allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry.

    This will be compared between the beginning and end of the trial and among active groups and placebo.



Secondary Outcome Measures :
  1. Dose finding skin prick test [ Time Frame: 4 months ]
    Comparison between the beginning and end of the trial and among active groups and placebo

  2. Number of participants with treatment-related adverse events as assessed by MM09-SIT-013 [ Time Frame: 4 months ]
    Comparison between the beginning and end of the trial and among active groups and placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661854


Contacts
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Contact: Antonio Nieto, PhD; MD +34961244378 antonio.nieto@me.com
Contact: Miguel Casanovas, PhD; MD +34916510010 mcasanovas@inmunotek.com

Locations
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Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03203
Contact: Isabel Flores Martín, MD    +34 966 616 900    isafloresmartin@hotmail.es   
Principal Investigator: Isabel Flores Martín         
Hospital Del Vinalopo Recruiting
Elche, Alicante, Spain, 03293
Contact: Mónica Antón, MD    +34 966 67 98 00    manton@vinaloposalud.com   
Principal Investigator: Mónica Antón         
Hospital General Universitario de Elda-Virgen de La Salud Recruiting
Elda, Alicante, Spain, 03600
Contact: Vicente Jover, MD    +34 966 98 90 00    algena00@hotmail.com   
Principal Investigator: Vicente Jover         
Hospital Vega Baja Orihuela Recruiting
Orihuela, Alicante, Spain, 03314
Contact: Carmen Andreu, MD    +34 965 87 75 00    candreub@hotmail.es   
Principal Investigator: Carmen Andreu         
Hospital Universitari de Castelló Recruiting
Castellón de la Plana, Castellón, Spain, 12004
Contact: Antonio de Mateo, MD    +34 964 72 65 00    dmateo_hos@gva.es   
Principal Investigator: Antonio de Mateo         
Hospital de La Plana Recruiting
Vila-real, Castellón, Spain, 12540
Contact: David El-Qutob, MD    +34 964 35 76 00    labour_david@hotmail.com   
Hospital de Manises Recruiting
Manises, Valencia, Spain, 46940
Contact: Pilar Alba, MD    +34 961 84 50 00    Alba48918@hotmail.com   
Principal Investigator: Pilar Alba         
Hospital Lluis Alcanyis de Xátiva Recruiting
Xátiva, Valencia, Spain, 46800
Contact: Luis Angel Navarro Seisdedos, MD    +34 962 28 95 00    luisangeln1@gmail.com   
Principal Investigator: Luis Angel Navarro Seisdedos         
Hospital General Universitario de Alicante Recruiting
Alicante, Spain, 03010
Contact: Javier Fernáncez, MD    +34 965 93 30 00    fernandez_jva@gva.es   
Principal Investigator: Luis Moral, MD         
Hospital Vithas Internacional Medimar Recruiting
Alicante, Spain, 03016
Contact: Ángel Ferrer, MD         
Contact    +34 902 29 82 99    angelyferrer@gmail.com   
Principal Investigator: Ángel Ferrer         
Hospital Arnau de Vilanova Recruiting
Valencia, Spain, 46015
Contact: Javier Montoro, MD    +34 996 386 85 00    montoro_fra@gva.es   
Principal Investigator: Javier Montoro         
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain, 46017
Contact: Carmen Pérez Francés, MD    +34 96 162 23 00    carmenfrances29@gmail.com   
Principal Investigator: Carmen Pérez Francés         
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults Recruiting
Valencia, Spain, 46026
Contact: Mª Dolores Hernández Fernández de Rojas, MD    +34961244378    hernandez_dol@gva.es   
Principal Investigator: Mª Dolores Hernández Fernández de Rojas         
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child Recruiting
Valencia, Spain, 46026
Contact: Antonio Nieto, PhD; MD    +34 961 244 378    antonio.nieto@me.com   
Principal Investigator: Antonio Nieto         
Sponsors and Collaborators
Inmunotek S.L.
Investigators
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Principal Investigator: Mª Dolores Hernández, PhD; MD
Principal Investigator: Pilar Alba, PhD; MD
Principal Investigator: Carmen Pérez, PhD; MD
Principal Investigator: Javier Montoro, PhD; MD
Principal Investigator: Antonio de Mateo, PhD; MD
Principal Investigator: David El-Qutob, PhD; MD
Principal Investigator: Javier Fernández, PhD; MD
Principal Investigator: Vicente Jover, PhD; MD
Principal Investigator: Isabel Flores, PhD; MD
Principal Investigator: Mónica Antón, PhD; MD
Principal Investigator: Carmen Andreu, PhD; MD
Principal Investigator: Luis Angel Navarro, PhD; MD
Principal Investigator: Ángel Ferrer
Study Director: Antonio Nieto, PhD; MD

Publications:

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Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT02661854     History of Changes
Other Study ID Numbers: MM09-SIT-013
2015-000820-27 ( EudraCT Number )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inmunotek S.L.:
Rhinitis / Rhinoconjunctivitis
Vaccine
Immunotherapy
Mite
Allergy

Additional relevant MeSH terms:
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Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases