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Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

Primary Purpose

Rhinitis, Allergic, Rhinoconjunctivitis, Asthma, Allergic

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
10,000 MG01 +10,000 T521
30,000 MG01 +10,000 T521
Placebo subcutaneous
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic focused on measuring Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Immunotherapy, Grass, cupressaceae

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent.
  2. Aged between 14 and 65, both genders
  3. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen.
  4. Subjects with a positive skin prick-test (wheal sixe >5 mm diameter). The positive and negative control of the test should give consistent results and whose determination does not exceed 1 year prior to the baseline visit.
  5. Specific immunoglobulin E ≥ class 3 , against grass and cupressaceae pollen (InmunoCAP® o Immulite) and whose determination does not exceed 1 year prior to the inclusion visit.
  6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.
  7. Women of childbearing potential, and men participating in the trial, should commit to using an appropriate 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.
  8. Subjects with asthma must be diagnosed according to the GEMA 5.0 guideline.
  9. Subjects capable of complying with the dosing regimen.
  10. Subjects who own a smartphone for symptom registration and medication

Exclusion Criteria:

  1. Subjects polisensitised to other aeroallergens but sensitisation to epithelia with exposure and occasional symptoms or sensitisation to pollen noncoseasonal with cupressus or grasses.
  2. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
  3. Subjects in which immunotherapy may be subject to 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.
  4. Subjects have not granted written informed consent.
  5. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
  6. Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test.
  7. Subjects treated with beta-blockers.
  8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
  9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
  10. Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).
  11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,).
  12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
  13. Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders.
  14. Subjects with a known allergy to components of the investigational medicinal product other than the allergen.
  15. Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis.
  16. Subjects who are direct relatives of the researchers.
  17. Pregnant or lactating women.

Sites / Locations

  • Hospital Recoletas Felipe Ii
  • Hospital Universitario Principe de AsturiasRecruiting
  • Hospital Cruz Roja MadridRecruiting
  • Clínica OjedaRecruiting
  • Hospital Universitario Puerta de Hierro
  • Cedt de Tarancon
  • Hospital U. Fundación Alcorcón
  • Clínica Privada Murcia
  • Fundación Hospital Sant Pere ClaverRecruiting
  • Hospital Universitario de BurgosRecruiting
  • Clinica privada
  • Clínica SubizaRecruiting
  • CAP José Marva
  • Clínica Privada
  • Clinica privadaRecruiting
  • Hospital Clínico de SalamancaRecruiting
  • Clinica Privada Soria
  • Clínica Privada Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

10,000 MG01 + 10,000 T521

30,000 MG01 + 10,000 T521

Placebo subcutaneous

Arm Description

10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

The same solution and presentation as the active treatment, but without active ingredients.

Outcomes

Primary Outcome Measures

CSMS: Combined Symptoms and Medication Score, asthma and rhinitis.
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.

Secondary Outcome Measures

Medication free days
Both rhinitis/rhinoconjunctivitis and asthma
Symptom free days
Both rhinitis/rhinoconjunctivitis and asthma
Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026
Comparison between the beginning and end of the trial and among active groups and placebo
Quality of life associated with asthma
The quality of life associated with asthma will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 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 questionnaire score is the mean of the 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
VAS
Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side (0) = very bad and right side (10) = very well
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Health resource consumption
Counting the Health resource consumption: visits to specialists, telephone calls, test and analyses.
Quality of life associated with rhinitis
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).

Full Information

First Posted
January 4, 2021
Last Updated
November 18, 2022
Sponsor
Inmunotek S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04898283
Brief Title
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
Official Title
A RDPC, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of SCIT in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to Cupressaceae and Grasses.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek 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
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
Detailed Description
Double blind, multicenter, parallel, placebo controlled study. It includes 150 subjects sensitised to cupressaceae and grass pollen, from 14 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, multicentre, parallel-group study
Masking
ParticipantCare ProviderInvestigatorOutcomes 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. 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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10,000 MG01 + 10,000 T521
Arm Type
Experimental
Arm Description
10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Arm Title
30,000 MG01 + 10,000 T521
Arm Type
Experimental
Arm Description
30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Arm Title
Placebo subcutaneous
Arm Type
Placebo Comparator
Arm Description
The same solution and presentation as the active treatment, but without active ingredients.
Intervention Type
Biological
Intervention Name(s)
10,000 MG01 +10,000 T521
Intervention Description
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Intervention Type
Biological
Intervention Name(s)
30,000 MG01 +10,000 T521
Intervention Description
Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
Intervention Type
Other
Intervention Name(s)
Placebo subcutaneous
Intervention Description
The same solution and presentation as the active treatment, but without active ingredients
Primary Outcome Measure Information:
Title
CSMS: Combined Symptoms and Medication Score, asthma and rhinitis.
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medication free days
Description
Both rhinitis/rhinoconjunctivitis and asthma
Time Frame
12 months
Title
Symptom free days
Description
Both rhinitis/rhinoconjunctivitis and asthma
Time Frame
12 months
Title
Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026
Description
Comparison between the beginning and end of the trial and among active groups and placebo
Time Frame
12 months
Title
Quality of life associated with asthma
Description
The quality of life associated with asthma will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 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 questionnaire score is the mean of the 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
VAS
Description
Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side (0) = very bad and right side (10) = very well
Time Frame
12 months
Title
Asthmatic exacerbations
Description
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Time Frame
12 months
Title
Health resource consumption
Description
Counting the Health resource consumption: visits to specialists, telephone calls, test and analyses.
Time Frame
12 months
Title
Quality of life associated with rhinitis
Description
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Aged between 12 and 65, both genders Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen. Subjects with a positive skin prick-test (wheal size >5 mm diameter) to a standardized grass pollen extract (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to a one extract of the mixture and to a cupressaceae extract. Specific IgE ≥ 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite). Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial. Women of childbearing potential participating in the trial, should commit to using an appropriate 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. Subjects capable of complying with the dosing regimen. Subjects who own a smartphone for symptom registration and medication. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be <3,5 kU/L and without relevant symptomatology Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be <3,5 kU/L and without relevant symptomatology. Exclusion Criteria: Subjects with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms. Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen. Subjects in which immunotherapy may be subject to 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. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated. Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test. Subjects treated with beta-blockers. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.). Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema. Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.). Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,). Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies. Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders. Subjects with a known allergy to components of the investigational medicinal product other than the allergen. Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis. Subjects who are direct relatives of the researchers. Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Carretero, MD
Phone
947 28 18 00
Email
pcarreteroa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Casanovas, MD PhD
Phone
916510010
Email
mcasanovas@inmunotek.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Carretero, MD
Organizational Affiliation
Hospital Universitario de Burgos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Recoletas Felipe Ii
City
Valladolid
State/Province
Castilla Y León
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Principe de Asturias
City
Alcalá De Henares
State/Province
Comunidad De Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Barbarroja Escudero, DM
Facility Name
Hospital Cruz Roja Madrid
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Julio Laguna, DM
Facility Name
Clínica Ojeda
City
Madrid
State/Province
Comunidad De Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Ojeda, DM
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Comunidad De Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Cedt de Tarancon
City
Tarancon
State/Province
Cuenca
ZIP/Postal Code
16400
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital U. Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clínica Privada Murcia
City
Murcia
State/Province
Región De Murcia
ZIP/Postal Code
30006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Fundación Hospital Sant Pere Claver
City
Barcelona
ZIP/Postal Code
08004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Hermida Clarena, DM
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Carretero, MD
Phone
947 28 18 00
First Name & Middle Initial & Last Name & Degree
Pedro Carretero Anibarro, MD
First Name & Middle Initial & Last Name & Degree
Natalia Sofía Perea Lam, MD
First Name & Middle Initial & Last Name & Degree
Carmen Reinares Ten, MD
First Name & Middle Initial & Last Name & Degree
Patricia Alloza Gómez, MD
First Name & Middle Initial & Last Name & Degree
Reyes Pérez Giménez, MD
First Name & Middle Initial & Last Name & Degree
Laura Manzanedo Ortega, MD
First Name & Middle Initial & Last Name & Degree
Sonia del Pozuelo Aparicio, MD
Facility Name
Clinica privada
City
León
ZIP/Postal Code
24001
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clínica Subiza
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Subiza Garrido-Lestache
First Name & Middle Initial & Last Name & Degree
Concepción Barjau Buj
Facility Name
CAP José Marva
City
Madrid
ZIP/Postal Code
28020
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clínica Privada
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinica privada
City
Palencia
ZIP/Postal Code
34002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izaskun Leanizbarrutia De Bizkarralegorra, DM
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Gracia Bara, DM
First Name & Middle Initial & Last Name & Degree
Ignacio Jesús Dávila González, DM
Facility Name
Clinica Privada Soria
City
Soria
ZIP/Postal Code
42002
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clínica Privada Zaragoza
City
Zaragoza
ZIP/Postal Code
50004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Javier Pérez-Camo Choliz, DM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27939406
Citation
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.
Results Reference
background

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Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

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