Clinical trial NCT02654223: Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
Official title: Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis
Rhinoconjunctivitis
Keywords: Rhinitis / Rhinoconjunctivitis
Vaccine
Immunotherapy
Grass pollen
Allergy
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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

Eligibility 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 grass pollen allergy
* Subjects with a positive skin prick-test (wheal sixe \>6 mm diameter) Specific immunoglobulin E (IgE, CAP \>3) to grass pollen
* Age between 14 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 and or mites, cats or dogs, 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 grass pollen 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 pollen of grasses.
* 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.

Primary outcomes:
measure: Concentration required to elicit a positive response after nasal provocation test (NPT)
timeFrame: 4 months
Secondary outcomes:
measure: Dose finding skin prick test
timeFrame: 4 months
measure: Cytokine production by T cells specific allergen
timeFrame: 4 months
measure: Immunoglobulin production by B cells specific allergen
timeFrame: 4 months
measure: Phenotypic and functional analysis of dendritic cells
timeFrame: 4 months
measure: Number of participants with treatment-related adverse events as assessed by MG56-SIT-012
timeFrame: 4 months
Other outcomes:
Locations:
city: Aranjuez
country: Spain
facility: Clínica Atlas
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
city: Castilleja De La Cuesta
country: Spain
facility: Hospital Nisa Aljarafe
state: Sevilla
city: Dos Hermanas
country: Spain
facility: Hospital San Agustín
state: Sevilla
city: Madrid
country: Spain
facility: CLÍNICA Dr. SUBIZA
city: Madrid
country: Spain
facility: Clínica Ojeda
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: HOSPITAL UNIVERSITARIO 12 de OCTUBRE
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Viamed Santa Angola de la Cruz
city: Valladolid
country: Spain
facility: Clínica Alianza Médica
Study officials:
affiliation: Clinica Subliza
name: Javier Subiza, PhD; MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Carmen Diéguez, PhD; MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Ojeda
name: Pedro Ojeda, PhD; MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Infanta Elena
name: Javier Ruiz Hornillos, PhD; MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta de Hierro
name: Matilde Domínguez, PhD; MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramón y Cajal
name: Emilio Solano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Atlas
name: Antonio Moreno
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen Macarena
name: Pedro Guardia
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Viamed Santa Ángela de la Cruz
name: Agustín Orovigt
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Agustín
name: Alberto Caso
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Alianza Médica
name: Alicia Alonso
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nisa Sevilla Aljarafe
name: Amparo Conde
role: PRINCIPAL_INVESTIGATOR
References: