Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma

NCT03821077 | Completed

• 1 other identifier: ROX-ALE-2018-01
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 10

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).

Conditions

Rhinitis, Allergic; Rhinoconjunctivitis

Keywords

Allergen immunotherapy (AIT); Rhinitis; Rhinoconjunctivitis; Subcutaneous Immunotherapy (SCIT); Allergovac Poliplus

Outcome Measures

Primary Outcomes (1)

• Combined Symptoms and Medication Score (CSMS)

  The score ranged from 0 to 6 points and is obtained as follows: Symptoms Score (SS) (from 0 to 3 points) + Medication Score (MS) (from 0 to 3 points). Through these 2 sub-scales the total score of the Combined Symptom and Medication Scale (CSMS) is obtained as follows: CSMS = SS (0-3) + MS (0-3) = 0-6 points The 0 value indicate no symptoms and no medication, and 6 points indicate the worst state of symptoms and the highest medication step

  Basal-12 months

Secondary Outcomes (5)

• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  Basal-12 months

• Total number, percentage, severity and gradation of adverse reactions

  Basal- 6 months-12 months

• Patient´s Tolerability assessment using a Likert-type scale

  6 months-12 months

• Patient's perception of the improvement in their global status using a Likert-type scale

  12 months

• Patient's Satisfaction using a Likert scale

  12 months

Interventions

Allergen Immunotherapy (AIT) BIOLOGICAL

Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation

Also known as: Allergovac Poliplus

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (10)

Centre Assistencial Baix Llobregat

Cornellà de Llobregat, Barcelona, Spain

Location

Hospital de Igualada

Igualada, Barcelona, Spain

Location

GAME Centre Medic

Sant Boi de Llobregat, Barcelona, Spain

Location

Fundación Hospital Calahorra

Calahorra, La Rioja, Spain

Location

CAR SAn Millán

Logroño, La Rioja, Spain

Location

Centro médico Promosalud

Logroño, La Rioja, Spain

Location

Allercen

Barcelona, Spain

Location

Centre Medic Catalonia

Barcelona, Spain

Location

Hospital QuironSalud Barcelona

Barcelona, Spain

Location

Hospital Sanitas CIMA

Barcelona, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: August 30, 2018
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)