Health TrialsbyHealthPanel

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

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

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject who has signed the informed consent.

Subjects of both sexes aged between 12 and 65 years.

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

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.

Disqualifiers

Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms

Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive

Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.

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 T517

    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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

  • 30,000 MG01 + 10,000 T517

    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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

  • Placebo

    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 T517Experimental treatment 1 intervention
Group B: 30,000 MG01 + 10,000 T517Experimental treatment 1 intervention
Group C: Placebo subcutaneousPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

CSMS: Combined Symptoms and Medication Score

Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day

Time frame
12 months

Secondary outcomes

1

Medication-free days

Number of days that the subjects need no medication

Time frame
12 months
2

Symptom-free days

Number of days that the subjects have no symptom

Time frame
12 months
3

Asthmatic exacerbations

Time elapsed until the first appearance of asthmatic exacerbations

Time frame
12 months
4

Visual Analogue Scale (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 very bad and right side very well

Time frame
12 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
Apply now