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

ConditionsRhinitis, AllergicRhinoconjunctivitisAsthma, Allergic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorInmunotek S.L.

About this trial

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of the molecular components of the mixture and to a cupressaceae extract. In addition, the largest diameter of the papules must be greater than or equal to that of the histamine.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 10,000 MG01 +10,000 T521

    Biological/Vaccine

    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

  • 30,000 MG01 +10,000 T521

    Biological/Vaccine

    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.

  • Placebo subcutaneous

    Other intervention

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: 10,000 MG01 + 10,000 T521Experimental treatment 1 intervention
Group B: 30,000 MG01 + 10,000 T521Experimental treatment 1 intervention
Group C: Placebo subcutaneousPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

RCSMS: Combined Symptoms and Medication Score of rhinitis. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS)

Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in rhinitis / rhinoconjunctivitis of each subject during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June), of the groups with each other and with respect to placebo.

Time frame
18 months

Secondary outcomes

1

Symptom free days

The number of days during the trial period that the subject was free of symptoms related to the study pathologies (both rhinitis/rhinoconjunctivitis and asthma) shall be counted for each subject.

Time frame
18 months
2

Medication free days

The number of days during the trial period that the subject has not taken any medication for symptom (both rhinitis/rhinoconjunctivitis and asthma) relief shall be counted for each subject.

Time frame
18 months
3

Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae

The rhinitis/rhinoconjunctivitis-related symptom score shall be counted throughout the trial period for each subject.

Time frame
18 months
4

Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae

The rhinitis/rhinoconjunctivitis-related medication score will be counted throughout the trial period for each subject.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inmunotek S.L.

Lead sponsor

Source ClinicalTrials.gov
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