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

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ClinicalTrials.gov Identifier: NCT02849249
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Roxall Medicina España S.A

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.

Condition or disease Intervention/treatment Phase
Rhinoconjuntivitis Biological: allergovac polimerized (100/100) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Biological: allergovac polimerized (100/100)
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Other Name: Allergovac Poliplus

Active Comparator: 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.
Biological: allergovac polimerized (100/100)
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Other Name: Allergovac Poliplus




Primary Outcome Measures :
  1. Number and severity of adverse reactions as a measure of safety and tolerabitity [ Time Frame: Across 12-15 weeks treatment period ]

Secondary Outcome Measures :
  1. Immunoglobulin changes from baseline [ Time Frame: At baseline and 1 week after last administered dose ]
    Subrogate efficacy

  2. Skin reactivity changes from baseline [ Time Frame: At baseline and 1 week after last administered dose ]
    Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849249


Locations
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Spain
Hospital de Zafra
Zafra, Badajoz, Spain, 06300
Hospital de Henares
Henares, Madrid, Spain
Hospital Clínico Granada
Granada, Spain, 18012
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Roxall Medicina España S.A
Investigators
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Study Director: María C Gómez, Dr. Roxall Medicina España S.A

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Responsible Party: Roxall Medicina España S.A
ClinicalTrials.gov Identifier: NCT02849249     History of Changes
Other Study ID Numbers: BIA-OLEAPHL-POLI-100
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Keywords provided by Roxall Medicina España S.A:
allergy
Immunotherapy
SCIT