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

NCT02849249 | Completed Phase 1

• 1 other identifier: BIA-OLEAPHL-POLI-100
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

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

Keywords

allergy; Immunotherapy; SCIT

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse reactions as a measure of safety and tolerabitity

  Across 12-15 weeks treatment period

Secondary Outcomes (2)

• Immunoglobulin changes from baseline

  At baseline and 1 week after last administered dose

• Skin reactivity changes from baseline

  At baseline and 1 week after last administered dose

Study Arms (2)

One day schedule

ACTIVE COMPARATOR

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.

Biological: allergovac polimerized (100/100)

Rapid schedule

ACTIVE COMPARATOR

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.

Biological: allergovac polimerized (100/100)

Interventions

allergovac polimerized (100/100) BIOLOGICAL

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

Also known as: Allergovac Poliplus

One day schedule; Rapid schedule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must sign the Informed Consent Form.
• Patients must be between 18 and 60 years of age.
• 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.
• Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
• Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
• 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:
• Overlapping seasonal pollens which are cross-reactive with Phleum pratense and Olea europaea.
• Pollens whose seasons do not overlap with Phleum pratense or Olea europaea and which are not expected to produce symptoms during the study period.
• Other allergens which are not expected to produce symptoms during the study period.
• Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
• Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.

You may not qualify if:

• 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.
• Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
• 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.
• Patients with a previous history of anaphylaxis
• Patients with chronic urticaria,
• Patients with moderate to severe atopic dermatitis
• Patients who have participated in another clinical trial within 3 month prior to enrolment.
• Patients under treatment with tricyclic antidepressives, phenothiazines , β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
• Female patients who are pregnant or breast-feeding
• Patient who does not attend the visits

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (5)

Hospital de Zafra

Zafra, Badajoz, 06300, Spain

Location

Hospital de Henares

Henares, Madrid, Spain

Location

Hospital Clínico Granada

Granada, 18012, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• María C Gómez, Dr.

  Roxall Medicina España S.A

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ES (5)