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

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ClinicalTrials.gov Identifier: NCT03821077
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Roxall Medicina España S.A

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).

Condition or disease Intervention/treatment
Rhinitis, Allergic Rhinoconjunctivitis Biological: Allergen Immunotherapy (AIT)

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Intervention Details:
  • Biological: Allergen Immunotherapy (AIT)
    Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
    Other Name: Allergovac Poliplus


Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821077


Contacts
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Contact: Leire Begoña, MSc 944 43 80 00 leire.begona@roxall.es
Contact: Begoña Madariaga, MD 944 43 80 00 begona.madariaga@roxall.es

Locations
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Spain
Centre Assistencial Baix Llobregat Recruiting
Cornellà De Llobregat, Barcelona, Spain
Principal Investigator: Cesar Alias, MD         
Hospital de Igualada Recruiting
Igualada, Barcelona, Spain
Principal Investigator: Marcia Dias, MD         
GAME Centre Medic Recruiting
Sant Boi De Llobregat, Barcelona, Spain
Principal Investigator: Carolina Escobar, MD         
Fundación Hospital Calahorra Recruiting
Calahorra, La Rioja, Spain
Principal Investigator: Rosario Escudero, MD         
CAR SAn Millán Recruiting
Logroño, La Rioja, Spain
Principal Investigator: Teófilo Lobera, MD         
Centro médico Promosalud Recruiting
Logroño, La Rioja, Spain
Principal Investigator: Catalina Vela, MD         
Allercen Recruiting
Barcelona, Spain
Principal Investigator: Jose Miguel Soler-Escoda, MD         
Centre Medic Catalonia Recruiting
Barcelona, Spain
Principal Investigator: Esther Pinto, MD         
Hospital QuironSalud Barcelona Recruiting
Barcelona, Spain
Principal Investigator: María Rueda, MD         
Hospital Sanitas CIMA Recruiting
Barcelona, Spain
Principal Investigator: Glennys Peralta, MD         
Sponsors and Collaborators
Roxall Medicina España S.A

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Responsible Party: Roxall Medicina España S.A
ClinicalTrials.gov Identifier: NCT03821077     History of Changes
Other Study ID Numbers: ROX-ALE-2018-01
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roxall Medicina España S.A:
Allergen immunotherapy (AIT)
Rhinitis
Rhinoconjunctivitis
Subcutaneous Immunotherapy (SCIT)
Allergovac Poliplus

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Physiological Effects of Drugs