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Completed

NCT Number: NCT03821077

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

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).

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Key information

Conditions

Rhinitis, Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinoconjunctivitis

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Assistencial Baix Llobregat, Cornellà de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Allergen Immunotherapy (AIT)

Biological

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

Other names: Allergovac Poliplus

Primary outcomes

  1. Combined Symptoms and Medication Score (CSMS)

    Time frame: Basal-12 months

    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

Secondary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

    Time frame: Basal-12 months

    The RQLQ has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). It is a self-administered questionnaire where patients respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores reflect lower quality of life.

  2. Total number, percentage, severity and gradation of adverse reactions

    Time frame: Basal- 6 months-12 months

    Total number, percentage, severity and gradation of adverse reactions reported (local and systemics), in relation to the total number of patients and the total administered doses, both globally and according to each administration schedule.

  3. Patient´s Tolerability assessment using a Likert-type scale

    Time frame: 6 months-12 months

    Patient´s Tolerability assessment using a Likert-type scale, with a score of 1 to 4 points (from 1 = I have tolerated it very well to 4 = I have tolerated it very badly)

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

    Time frame: 12 months

    Evaluation of the patient's perception of the improvement in the global state of the pathology, using a Likert-type scale, with a score of 1 to 4 points (from 1= good or excellent improvement to 4 = worsening)

  5. Patient's Satisfaction using a Likert scale

    Time frame: 12 months

    Degree of patients' satisfaction with the treatment using a Likert scale, with a score of 1 to 4 points (from 1 = Very Satisfied to 4 = Very dissatisfied)

Sponsors and collaborators

Lead sponsor

Roxall Medicina España S.A

Industry

Registry information

Official study 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

Acronym: ARES

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2019
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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