Phase I, open, multicenter study, with subcutaneous immunotherapy in depot presentation, in patients with rhinoconjunctivitis sensitized to Olea europaea.

Phase 1

• Conditions: Rhinoconjunctivitis; MedDRA version: 19.1Level: LLTClassification code 10039097Term: RhinoconjunctivitisSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-001569-29-ES
• Lead Sponsor: BIAL Industrial Farmaceutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-03
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Patients must sign the informed consent form.
2. Patients must be between 18 and 60 years of age.
3. Patients with seasonal rhinoconjunctivitis against Olea europaea during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with
mild concomitant asthma is allowed.
4. Patients who obtained a prick test result over 3 mm diameter to Olea europaea. Positive and negative control of the test should give consistent results.
5. Patients with a value of specific IgE equel or superior to class 2 (CAP/PHADIA) to Olea europaea.
6. Patients will sensitized to Olea europaea with clinically relevant symptomatology to its exposal.
7. Patients who comply with all treatment windows as described per protocol for both study treatment and procedures.
8. Women with menarche must have a negative urine pregnancy test prior to their enrolment in the study, as well as agree to use an appropriate
contraception method during the study if they are sexually active.
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 49
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who received immunotherapy in the previous 5 years for Olea europaea or for any allergen with cross reactivity or patients that are currently
receiving immunotherapy for any allergen.
2. Patients with severe asthma or FEV1< 70%, although it is controlled with medication.
3. Patients with immunological, cardiac, renal or hepatic illnesses or any other
medical condition that the investigator deems relevant so as to interfere with
the study.
4. Patients with a previous history of anaphylaxis
5. Patients with chronic urticaria.
6. Patients with moderate to severe atopic dermatitis
7. Patients who have participated in another clinical trial within 3 month prior to
enrolment.
9. Female patients who are pregnant or breast-feeding
10. Patients under treatment with tricyclical antidepressives, phenotiazines, -blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
11. Patient who does not attend the visits
12. Patient?s lack of collaboration or refusal to participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified