Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
NCT02844842 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152
Last updated 2019-01-25
Summary
This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.
The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
Conditions
- Allergic Rhinitis
- Rhinoconjunctivitis
- Asthma
Interventions
- BIOLOGICAL
-
Allergovac Poliplus
Sponsors & Collaborators
-
Roxall Medicina España S.A
lead INDUSTRY
Eligibility
- Min Age
- 5 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-23
- Primary Completion
- 2018-09-06
- Completion
- 2018-09-06
Countries
- Spain
Study Locations
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