Biological standardization of pollen of Phleum pratense, Olea europaea, mite extract Dermatophagoides pteronyssinus and animal allergen Felis domesticus.

Biological standardization of pollen of Phleum pratense, Olea europaea, mite extract Dermatophagoides pteronyssinus and animal allergen Felis domesticus. Open label, single center, phase II study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005362-35-ES

Enrollment

100

Registered

2013-02-04

Start date

2013-04-09

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biological standardization for allergenic extracts in patients with hipersensibility to extracts MedDRA version: 20.0 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: Dermatophagoides pteronyssinus Product Code: DP Pharmaceutical Form: INN or Proposed INN: European house dust mite Other descriptive name: DERMATOPHAGOIDES PTERONYSSINUS Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent signed and dated by the patient/witness. Patients living inan area where the allergen is considered as a relevant health problem. Medical history supporting the allergy to the allergen. Positive diagnosis to the allergen Specific IgE positive for any of the allergens Age range between 18 and 64 years old for both genders Negative pregnancy test for fertile women Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who had received previous immunotherapy within the previous 2 years Patients who had received within the previous 15 day sany intake of drugs able to interfere in the Skin Prick test (e.g. anti histaminic, topic corticoids, ? blockers or tryciclic antidepresives). Pregnant women or breast feeding Patients who has received systemic corticoids (dose greater than 30 mg prednisone/day) for longer than a week. Patients with cutaneous reactions which can modify the response (e.g. Dermographism, dermatitis, severe asthma, hipersensibility to phenol or any of the components of the prick test)

Design outcomes

Primary

Measure	Time frame
Main Objective: The biological characterization of allergen extracts;Secondary Objective: To determine the specificity of extracts in patients with hipersensibility. To determine the optimal dose of the allergen extract on skin test.;Primary end point(s): Cutaneous reaction to the extract;Timepoint(s) of evaluation of this end point: 30 minutes	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Spain

Contacts

Public ContactFrancisco M. Marco

nstituto de Inmunología y Alergia INMUNAL SAU

fm.marco@inmunal.es0034618735731

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026