Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

May 5, 2025 updated by: Inmunotek S.L.

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen

Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Double blind, multicenter, parallel, placebo controlled study. It includes 180 subjects sensitised to olea and grass pollen with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma, from 12 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02003
        • Withdrawn
        • Private Practice
      • Badajoz, Spain, 06001
        • Recruiting
        • Clínica Dermatológica y Alergia
        • Principal Investigator:
          • Irán Sánchez Ramos, MD
      • Badajoz, Spain, 06011
        • Recruiting
        • Hospital Quironsalud Clideba
        • Principal Investigator:
          • Silvia Sánchez, MD
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitario Dexeus
        • Principal Investigator:
          • Elena Botey Faraudo, MD
      • Barcelona, Spain, 08172
        • Withdrawn
        • Clínica privada Barcelona
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario Ciudad Real
        • Principal Investigator:
          • Carmen García, MD
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Quirónsalud Córdoba
        • Principal Investigator:
          • Ignacio Garcia Núñez, MD
      • Granada, Spain, 18016
        • Active, not recruiting
        • Hospital Universitario Clínico San Cecilio
      • Jaén, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaen
        • Sub-Investigator:
          • Carmen Laura Cañada Porta, MD
        • Sub-Investigator:
          • María Antonia Navarrete del Pimo, MD
        • Principal Investigator:
          • Manuel Alcántara Villar, MD
        • Sub-Investigator:
          • Miriam Bermúdez Bejarano, MD
        • Sub-Investigator:
          • Alicia López Guerrero, MD
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitari Santa Maria
        • Principal Investigator:
          • Eva Alcoceba Borrás, MD
      • Madrid, Spain, 28006
        • Recruiting
        • Clínica Subiza
        • Principal Investigator:
          • Javier Subiza Garrido-Lestache, MD
        • Sub-Investigator:
          • Concepción Barjau Buj, MD
      • Madrid, Spain, 28003
        • Recruiting
        • Hospital Universitario Cruz Roja
        • Principal Investigator:
          • Jose Julio Laguna, MD
        • Sub-Investigator:
          • Cosmin Boteau, MD
        • Sub-Investigator:
          • Rosario González, MD
        • Sub-Investigator:
          • Inmaculada Piorno, MD
        • Sub-Investigator:
          • Maria Luisa Sánchez, MD
      • Madrid, Spain, 28006
        • Recruiting
        • Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
        • Principal Investigator:
          • Pedro Ojeda, MD
        • Sub-Investigator:
          • David Baquero, MD
      • Madrid, Spain, 28001
        • Withdrawn
        • Private Practice
      • Madrid, Spain, 28029
        • Completed
        • Hospital Carlos III
      • Madrid, Spain, 28933
        • Withdrawn
        • Hospital Universitario Rey Juan Carlos
      • Murcia, Spain
        • Recruiting
        • Private Practice
        • Principal Investigator:
          • Antonio Carbonell, MD
        • Sub-Investigator:
          • Yulia Petryk Petryk, MD
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quironsalud Malaga
        • Principal Investigator:
          • Leticia Herrero, DM
      • Málaga, Spain
        • Recruiting
        • Private Practice
        • Principal Investigator:
          • Manuel Barceló, DM
      • Palencia, Spain, 34001
        • Completed
        • Private Practice
      • Parla, Spain, 28981
        • Recruiting
        • Hospital Universitario Infanta Cristina
        • Principal Investigator:
          • Aurora Losada, MD
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Virgen Del Rocio
        • Principal Investigator:
          • Joaquín Quiralte Enriquez, MD
        • Sub-Investigator:
          • Yolanda Puente Crespo, MD
        • Sub-Investigator:
          • María del Robledo Ávila Castellano, MD
        • Sub-Investigator:
          • Carmen Rodríguez Pozo, Nurse
        • Sub-Investigator:
          • Esteban Romero Rueda, Nurse
      • Sevilla, Spain, 41014
        • Recruiting
        • Hospital Viamed Santa Angela De la Cruz
        • Principal Investigator:
          • MÓNICA DONADO NORTES, MD
      • Sevilla, Spain, 41005
        • Withdrawn
        • Clínica privada Sevilla
      • Toledo, Spain, 45005
        • Withdrawn
        • Private Practice
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Recoletas Felipe Ii
        • Principal Investigator:
          • Alicia Alonso, DM
      • Ávila, Spain, 05004
        • Recruiting
        • Hospital Ntra. Sra. de Sonsoles
        • Principal Investigator:
          • Sara Acero, MD
    • Comunidad De Madrid
      • Alcalá De Henares, Comunidad De Madrid, Spain, 28805
        • Completed
        • Hospital Universitario Príncipe de Asturias
    • Cuenca
      • Tarancon, Cuenca, Spain, 16400
        • Recruiting
        • Cedt de Tarancón
        • Principal Investigator:
          • Antonio Moreno Fernández, MD
    • Madrid
      • Tres Cantos, Madrid, Spain, 28760
        • Recruiting
        • Centro Médico Iza
        • Contact:
          • Diana Pérez Alzate
        • Principal Investigator:
          • Diana Pérez Alzate, MD
      • Valdemoro, Madrid, Spain, 28342
        • Recruiting
        • Hospital Infanta Elena
        • Principal Investigator:
          • FRANCISCO JAVIER RUIZ HORNILLOS, DM
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de Arrixaca
        • Principal Investigator:
          • PAOLA CARRILLO, DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject who has signed the informed consent.
  2. Subjects of both sexes aged between 12 and 65 years.
  3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
  4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
  5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value > 3,5 KU / L.
  6. Women of childbearing age (from menarche) should submit 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 capable of complying with the dosage regimen.
  9. Subjects who have a smartphone to record symptoms and medication.
  10. 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
  11. 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:

  1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
  2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
  3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
  4. 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.
  5. Subjects with severe or uncontrolled 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 presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
  7. Subjects under treatment with ß-blockers.
  8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
  9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, 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 the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
  11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
  12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
  13. Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
  14. Subjects with a known allergy to other investigational drug components other than the allergen.
  15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
  16. Subjects who are direct relatives of the researchers.
  17. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Other: Placebo
The same solution and presentation as the active treatment, but without active ingredients
Experimental: 10,000 MG01 + 10,000 T517
10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Biological: 10,000 MG01 + 10,000 T517
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Other Names:
  • Grasses and olea 10,000
Experimental: 30,000 MG01 + 10,000 T517
30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Biological: 30,000 MG01 + 10,000 T517
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Other Names:
  • Grasses and olea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CSMS: Combined Symptoms and Medication Score
Time Frame: 12 months
Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication-free days
Time Frame: 12 months
Number of days that the subjects need no medication
12 months
Symptom-free days
Time Frame: 12 months
Number of days that the subjects have no symptom
12 months
Security parameters
Time Frame: 12 months
Global rate and severity of AE per administration and per subject
12 months
Visual Analogue Scale (VAS)
Time Frame: 12 months
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 very bad and right side very well
12 months
Quality of life rhinitis test
Time Frame: 12 months
Quality of life rhinitis test (ESPRINT-15)
12 months
Quality of life asthma test
Time Frame: 12 months
Control of asthma by Asthma Control Quality questionnaire
12 months
Health resources
Time Frame: 12 months

For each patient, the number of times that due to allergy symptoms has done the following will be counted:

Have visited the GP, 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
12 months
Immunological parameters
Time Frame: 12 months
Analyses of total and specific IgE, specific Ig G4
12 months
Adverse Reactions
Time Frame: 12 months
Local and systemic reactions and any medication administered for the treatment of AR
12 months
Asthmatic exacerbations
Time Frame: 12 months
Time elapsed until the first appearance of asthmatic exacerbations
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inmunotek S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Irán Sánchez, Private Site

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMV03-SIT-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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