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

Primary Purpose

House Dust Mite Allergy, Perennial Allergic Rhinitis, Allergic Rhinoconjunctivitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)
MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)
MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)
Placebo subcutaneous
Placebo sublingual
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for House Dust Mite Allergy focused on measuring Rhinitis/ Rhinoconjunctivitis, Allergy, Immunotherapy, Mild to moderate asthma

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated Informed Consent Form (ICF).
  2. Female or male aged 12 to 60 years, both included.
  3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
  4. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
  5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
  6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
  7. Women of childbearing age must commit to using an adequate contraception method.
  8. Capable of complying with dosage regimen.
  9. Owning a smartphone to register symptoms and medication consumption.
  10. A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance.

Exclusion Criteria:

  1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
  2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
  3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
  4. Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
  5. Intake of β-blockers.
  6. Use of immunosuppressive or biological drug.
  7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
  8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
  9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
  10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
  11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
  12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
  13. Known allergy to any of the ingredients of the study medication except for mites.
  14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
  15. Breast-feeding or pregnant women.
  16. Being immediate family of the investigator.
  17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
  18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.

Sites / Locations

  • Hospital Universitario de Elche
  • Policlínica Nuestra Sra del Rosario
  • Hospital Sant Joan de Déu
  • Hospital de Terrassa
  • Hospital Universitario de Navarra
  • Hospital Universitario de Canarias
  • Hospital Universitario A Coruña
  • Hospital General Universitario de Alicante
  • Centro Médico Quiron Salud Alicante
  • Clínica RUSADIR
  • Hopital Quirón Salud Málaga
  • Clinica del Dr.Pérez Estrada Cornejo
  • Hospital Universitario Regional de Málaga
  • Complexo Hospitalario Universitario de Pontevedra
  • Hospital Univeristario y Politécnico La Fe
  • Hospital Universitario de la Plana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo

Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo

Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo

Group IV: Placebo

Arm Description

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3,000 UTm/mL subcutaneous immunotherapy + sublingual placebo. Subcutaneous active treatment will be administered once a month for 12 months. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months.

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 3.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.

Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 9.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.

Mixture of sublingual placebo + subcutaneous placebo. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months

Outcomes

Primary Outcome Measures

CSMS: Combined Symptoms and Medication Score
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo. - The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe Total daily symptom score = 0-3 The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide. The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3

Secondary Outcome Measures

Asthma symptom-free days
Number of days that subjects have no symptoms related to asthma
Rhinitis / rhinoconjunctivitis symptom-free days
Number of days that subjects have no symptom related to rhinitis / rhinoconjunctivitis.
Asthma medication-free days
Number of days that subjects need no medication for treatment of asthma.
Rhinitis / rhinoconjunctivitis medication-free days
Number of days that subjects need no medication for treatment of Rhinitis / rhinoconjunctivitis.
Respiratory function_FEV1
Measurement of Forced Expiratory Volume in 1 Second (FEV1) %
Respiratory function_PEF
Peak Expiratory Flow (PEF) [velocity]
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Clinical benefit
Time to onset of clinical benefit
Immunological parameters
Analyses of total and specific IgE, specific IgE index / total IgE, specific IgG4 and Anti-Saccharomyces cerevisiae (ASCA) IgA&IgG.
Quality of life associated with asthma (AQLQ)
The quality of life associated with asthma will be measured using the Asthma Quality of Life Questionnaire (AQLQ). AQLQ consists of 32 items and 4 domains (limitations in activities, symptoms, emotional and environmental). Each item is scored from 1=no impairment to 7=severe impairment.
Quality of life associated with rhinoconjunctivitis (RQLQ)
The quality of life associated with rhinoconjunctivitis will be measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RQLQ it consists of 28 items (questions) and 7 domains (Activities, sleep, general symptoms, practical problems, nose symptoms, eye and emotional symptoms). The score of each item for all domains, except for the emotional one, ranges from "0=Nothing bothered me" to "6=It has bothered me a lot". The emotional domain score ranges from "0=Never" to "6=Always".
Questionnaire for asthma control (ACQ)
Asthma control will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from "0 = fully controlled" to "6 = extremely poorly controlled"). The seventh question, which refers to the% FEV1 of the reference value, must be completed by an employee of the site. The questionnaire score is the mean of the 7 responses (ACQ-7) or 6 responses (ACQ-6). The interpretation of the scores is as follows: Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control
Visual Analogue Scale (VAS)
Visual Analogue Scale in which the subject has to indicate in a straight line of 10 cm how he/she feels regarding to his allergy symptoms. Being left side "0 = very bad" and right side "10 = very well". VAS scale will also be completed by the investigator answering how he/she thinks that the patient feels.
Consumption of health resources
For each patient, the number of times that due to allergy symptoms has done the following will be counted: have visited the family doctor have made an unscheduled visit to the specialist has gone to the emergency room has been hospitalized have needed to contact the doctor by phone
Safety parameters
Global rate and severity of AE per administration and per subject
Number of Local Adverse Reactions
Local adverse reactions are those that appear at the site of the administration. They are classified into: Immediate (it appears during the first 30 minutes from the administration of investigational product) and Late (it appears after the first 30 minutes from the administration of investigational product)
Number of Systemic Adverse Reactions
Systemic adverse reactions are those that appear in other parts of the body other than the site of administration.Their severity will be classified following the indications proposed by the World Allergy Organization (WAO) in 2010.

Full Information

First Posted
May 27, 2022
Last Updated
November 17, 2022
Sponsor
Inmunotek S.L.
Collaborators
BioClever 2005 S.L., NTS hub S.L
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1. Study Identification

Unique Protocol Identification Number
NCT05400811
Brief Title
Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis
Official Title
Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.
Collaborators
BioClever 2005 S.L., NTS hub S.L

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
Detailed Description
Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms. The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
House Dust Mite Allergy, Perennial Allergic Rhinitis, Allergic Rhinoconjunctivitis, Allergic Asthma
Keywords
Rhinitis/ Rhinoconjunctivitis, Allergy, Immunotherapy, Mild to moderate asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, placebo-controlled, double-blind, double-dummy, multi-center trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed. 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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo
Arm Type
Experimental
Arm Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3,000 UTm/mL subcutaneous immunotherapy + sublingual placebo. Subcutaneous active treatment will be administered once a month for 12 months. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months.
Arm Title
Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo
Arm Type
Experimental
Arm Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 3.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.
Arm Title
Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo
Arm Type
Experimental
Arm Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 9.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months.
Arm Title
Group IV: Placebo
Arm Type
Placebo Comparator
Arm Description
Mixture of sublingual placebo + subcutaneous placebo. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months
Intervention Type
Biological
Intervention Name(s)
MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)
Intervention Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.
Intervention Type
Biological
Intervention Name(s)
MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)
Intervention Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.
Intervention Type
Biological
Intervention Name(s)
MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)
Intervention Description
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.
Intervention Type
Biological
Intervention Name(s)
Placebo subcutaneous
Intervention Description
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Intervention Type
Biological
Intervention Name(s)
Placebo sublingual
Intervention Description
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Primary Outcome Measure Information:
Title
CSMS: Combined Symptoms and Medication Score
Description
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo. - The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe Total daily symptom score = 0-3 The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide. The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma symptom-free days
Description
Number of days that subjects have no symptoms related to asthma
Time Frame
12 months
Title
Rhinitis / rhinoconjunctivitis symptom-free days
Description
Number of days that subjects have no symptom related to rhinitis / rhinoconjunctivitis.
Time Frame
12 months
Title
Asthma medication-free days
Description
Number of days that subjects need no medication for treatment of asthma.
Time Frame
12 months
Title
Rhinitis / rhinoconjunctivitis medication-free days
Description
Number of days that subjects need no medication for treatment of Rhinitis / rhinoconjunctivitis.
Time Frame
12 months
Title
Respiratory function_FEV1
Description
Measurement of Forced Expiratory Volume in 1 Second (FEV1) %
Time Frame
Baseline, month 6, month 12
Title
Respiratory function_PEF
Description
Peak Expiratory Flow (PEF) [velocity]
Time Frame
Baseline, month 6, month 12
Title
Asthmatic exacerbations
Description
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Time Frame
12 months
Title
Clinical benefit
Description
Time to onset of clinical benefit
Time Frame
12 months
Title
Immunological parameters
Description
Analyses of total and specific IgE, specific IgE index / total IgE, specific IgG4 and Anti-Saccharomyces cerevisiae (ASCA) IgA&IgG.
Time Frame
12 months
Title
Quality of life associated with asthma (AQLQ)
Description
The quality of life associated with asthma will be measured using the Asthma Quality of Life Questionnaire (AQLQ). AQLQ consists of 32 items and 4 domains (limitations in activities, symptoms, emotional and environmental). Each item is scored from 1=no impairment to 7=severe impairment.
Time Frame
12 months
Title
Quality of life associated with rhinoconjunctivitis (RQLQ)
Description
The quality of life associated with rhinoconjunctivitis will be measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RQLQ it consists of 28 items (questions) and 7 domains (Activities, sleep, general symptoms, practical problems, nose symptoms, eye and emotional symptoms). The score of each item for all domains, except for the emotional one, ranges from "0=Nothing bothered me" to "6=It has bothered me a lot". The emotional domain score ranges from "0=Never" to "6=Always".
Time Frame
Baseline, month 6, month 12
Title
Questionnaire for asthma control (ACQ)
Description
Asthma control will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from "0 = fully controlled" to "6 = extremely poorly controlled"). The seventh question, which refers to the% FEV1 of the reference value, must be completed by an employee of the site. The questionnaire score is the mean of the 7 responses (ACQ-7) or 6 responses (ACQ-6). The interpretation of the scores is as follows: Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control
Time Frame
12 months
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale in which the subject has to indicate in a straight line of 10 cm how he/she feels regarding to his allergy symptoms. Being left side "0 = very bad" and right side "10 = very well". VAS scale will also be completed by the investigator answering how he/she thinks that the patient feels.
Time Frame
12 months
Title
Consumption of health resources
Description
For each patient, the number of times that due to allergy symptoms has done the following will be counted: have visited the family doctor have made an unscheduled visit to the specialist has gone to the emergency room has been hospitalized have needed to contact the doctor by phone
Time Frame
12 months
Title
Safety parameters
Description
Global rate and severity of AE per administration and per subject
Time Frame
12 months
Title
Number of Local Adverse Reactions
Description
Local adverse reactions are those that appear at the site of the administration. They are classified into: Immediate (it appears during the first 30 minutes from the administration of investigational product) and Late (it appears after the first 30 minutes from the administration of investigational product)
Time Frame
12 months
Title
Number of Systemic Adverse Reactions
Description
Systemic adverse reactions are those that appear in other parts of the body other than the site of administration.Their severity will be classified following the indications proposed by the World Allergy Organization (WAO) in 2010.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated Informed Consent Form (ICF). Female or male aged 12 to 60 years, both included. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study. Women of childbearing age must commit to using an adequate contraception method. Capable of complying with dosage regimen. Owning a smartphone to register symptoms and medication consumption. A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance. Exclusion Criteria: Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee. Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment. Intake of β-blockers. Use of immunosuppressive or biological drug. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc). Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure). Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders. Known allergy to any of the ingredients of the study medication except for mites. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease. Breast-feeding or pregnant women. Being immediate family of the investigator. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Casanovas, MD, PhD
Phone
912908942
Ext
0034
Email
mcasanovas@inmunotek.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Tabar Purroy, MD. PhD
Organizational Affiliation
Hospital Universitario de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Policlínica Nuestra Sra del Rosario
City
Ibiza
State/Province
Baleares
ZIP/Postal Code
07800
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Martínez Blanco, MD, PhD
Facility Name
Hospital Sant Joan de Déu
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Machinena, MD. PhD
Facility Name
Hospital de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Viñas, MD. PhD
Facility Name
Hospital Universitario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Tabar Purroy, MD. PhD
Facility Name
Hospital Universitario de Canarias
City
San Cristóbal de La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Sánchez Machin, MD, PhD
Facility Name
Hospital Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Parra Arrondo, MD, PhD
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Moral, MD, PhD
Facility Name
Centro Médico Quiron Salud Alicante
City
Alicante
ZIP/Postal Code
03015
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Ferrer, MD, PhD
Facility Name
Clínica RUSADIR
City
Melilla
ZIP/Postal Code
52006
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Alexis Muñoz Daga, MD, PhD
Facility Name
Hopital Quirón Salud Málaga
City
Málaga
ZIP/Postal Code
29004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leticia Herrero Lifona, MD, PhD
Facility Name
Clinica del Dr.Pérez Estrada Cornejo
City
Málaga
ZIP/Postal Code
29005
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Pérez Estrada Cornejo, MD. PhD
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmén Rondón, MD, PhD
Facility Name
Complexo Hospitalario Universitario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Univeristario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario de la Plana
City
Vila-real
ZIP/Postal Code
12540
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco David El-Qutob López, MD. PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30546997
Citation
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Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis

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