Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma
Lead Sponsor:
Roxall Medicina España S.A
Conditions:
Rhinitis, Allergic
Rhinoconjunctivitis
Eligibility:
All Genders
5-60 years
Brief Summary
This is an observational prospective multicenter clinical study, to evaluate the efficacy and safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a mixture of 2 all...
Eligibility Criteria
Inclusion
- Patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis mediated by IgE, caused by sensitization to more than one allergenic source (pollens or mites) and with or without associated mild / moderate asthma.
- Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
- Patients who have given their signed informed consent.
Exclusion
- Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
- Patients who have received previous immunotherapy treatment, both subcutaneous (SCIT) and sublingual (SLIT), with any of the allergenic extracts that they plan to receive, in the 5 years prior to study inclusion.
- Patients who in the opinion of the investigator may present difficulties that prevent the understanding of what was written in the informed consent form or the completion of self-administered questionnaires / scales or the patient's diary.
- Patients who are participating in another clinical trial or observational study with any drug.
Key Trial Info
Start Date :
August 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03821077
Start Date
August 30 2018
End Date
September 13 2021
Last Update
October 20 2021
Active Locations (10)
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1
Centre Assistencial Baix Llobregat
Cornellà de Llobregat, Barcelona, Spain
2
Hospital de Igualada
Igualada, Barcelona, Spain
3
GAME Centre Medic
Sant Boi de Llobregat, Barcelona, Spain
4
Fundación Hospital Calahorra
Calahorra, La Rioja, Spain