A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

NCT ID: NCT02849249

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-30

Brief Summary

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Conditions

Rhinoconjuntivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One day schedule

Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day.

Group Type: ACTIVE_COMPARATOR

allergovac polimerized (100/100)

Intervention Type: BIOLOGICAL

Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

Rapid schedule

Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached.

Group Type: ACTIVE_COMPARATOR

allergovac polimerized (100/100)

Intervention Type: BIOLOGICAL

Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

Interventions

allergovac polimerized (100/100)

Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

Intervention Type: BIOLOGICAL

Other Intervention Names

Allergovac Poliplus

Eligibility Criteria

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 allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.

4. Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.

5. Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.

6. Patients will preferably be polysensitized to Phleum pratense. Polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by:

1. Overlapping seasonal pollens which are cross-reactive with Phleum pratense and Olea europaea.

2. Pollens whose seasons do not overlap with Phleum pratense or Olea europaea and which are not expected to produce symptoms during the study period.

3. Other allergens which are not expected to produce symptoms during the study period.

7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

8. Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

Exclusion Criteria

1. Patients who received immunotherapy in the previous 5 years for Phleum pratense and 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 forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .

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.

8. Patients under treatment with tricyclic antidepressives, phenothiazines , β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)

9. Female patients who are pregnant or breast-feeding

10. Patient who does not attend the visits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roxall Medicina España S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María C Gómez, Dr.

Role: STUDY_DIRECTOR

Roxall Medicina España S.A

Locations

Hospital de Zafra

Zafra, Badajoz, Spain

Hospital de Henares

Henares, Madrid, Spain

Hospital Clínico Granada

Granada, , Spain

Hospital Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

Other Identifiers

BIA-OLEAPHL-POLI-100

Identifier Type: -

Identifier Source: org_study_id