Clinical trial NCT03821077: Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma
Official title: Prospective Observational Study to Evaluate the Efficacy and Safety of Treatment With "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Associated Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Rhinoconjunctivitis
Keywords: Allergen immunotherapy (AIT)
Rhinitis
Rhinoconjunctivitis
Subcutaneous Immunotherapy (SCIT)
Allergovac Poliplus
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 122
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.

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 allergenic extracts (pollens or mites), in polymerized-depot formulation, administered in its different available allergenic extracts mixtures (2 pollens or 2 mites), and in one of the 2 recommended administration schedules (1 Day or Rapid).


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
3. Patients who have given their signed informed consent.

Exclusion Criteria:

1. Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
2. 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.
3. 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.
4. Patients who are participating in another clinical trial or observational study with any drug.

Primary outcomes:
measure: Combined Symptoms and Medication Score (CSMS)
timeFrame: Basal-12 months
Secondary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: Basal-12 months
measure: Total number, percentage, severity and gradation of adverse reactions
timeFrame: Basal- 6 months-12 months
measure: Patient´s Tolerability assessment using a Likert-type scale
timeFrame: 6 months-12 months
measure: Patient's perception of the improvement in their global status using a Likert-type scale
timeFrame: 12 months
measure: Patient's Satisfaction using a Likert scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Cornellà De Llobregat
country: Spain
facility: Centre Assistencial Baix Llobregat
state: Barcelona
city: Igualada
country: Spain
facility: Hospital de Igualada
state: Barcelona
city: Sant Boi De Llobregat
country: Spain
facility: GAME Centre Medic
state: Barcelona
city: Calahorra
country: Spain
facility: Fundación Hospital Calahorra
state: La Rioja
city: Logroño
country: Spain
facility: CAR SAn Millán
state: La Rioja
city: Logroño
country: Spain
facility: Centro médico Promosalud
state: La Rioja
city: Barcelona
country: Spain
facility: Allercen
city: Barcelona
country: Spain
facility: Centre Medic Catalonia
city: Barcelona
country: Spain
facility: Hospital QuironSalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Sanitas CIMA
Study officials:
References: