Rhinitis, AllergicARESNCT03821077
Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma
An observational study of Rhinitis, Allergic and Rhinoconjunctivitis, run by Roxall Medicina España S.A at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Rhinitis, Allergic, Rhinoconjunctivitis
- What is being tested?
- Allergen Immunotherapy (AIT)
- Type of treatment
- Vaccines
- How many people
- 122 participants
- Where
- 10 sitesSpain
- Study dates
- 30 Aug 2018to 13 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Allercen
Barcelona
Centre Medic Catalonia
Barcelona
Hospital QuironSalud Barcelona
Barcelona
Hospital Sanitas CIMA
Barcelona
Fundación Hospital Calahorra
Calahorra, La Rioja
Centre Assistencial Baix Llobregat
Cornellà de Llobregat, Barcelona
Hospital de Igualada
Igualada, Barcelona
CAR SAn Millán
Logroño, La Rioja
Centro médico Promosalud
Logroño, La Rioja
GAME Centre Medic
Sant Boi de Llobregat, Barcelona
About this study
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
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
- Being tested
- Allergen Immunotherapy (AIT)
- Keywords
- Allergen immunotherapy (AIT), Rhinitis, Rhinoconjunctivitis, Subcutaneous Immunotherapy (SCIT), Allergovac Poliplus
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen Immunotherapy (AIT)Biological
Also called Allergovac Poliplus
Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Basal-12 months
Secondary outcomes (5)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
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.
Measured: Basal-12 months
Total number, percentage, severity and gradation of adverse reactions
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.
Measured: Basal- 6 months-12 months
Patient´s Tolerability assessment using a Likert-type scale
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)
Measured: 6 months-12 months
Patient's perception of the improvement in their global status using a Likert-type scale
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)
Measured: 12 months
Patient's Satisfaction using a Likert scale
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start30 Aug 2018
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821077
- Sponsor's protocol ID
- ROX-ALE-2018-01
- Acronym
- ARES
- Status last verified
- Oct 2021
- First submitted
- 24 Jan 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03821077
- Acronym / sponsor ID
- ARES / ROX-ALE-2018-01
- Conditions
- Rhinitis, Allergic, Rhinoconjunctivitis
- Keywords
- Allergen immunotherapy (AIT), Rhinitis, Rhinoconjunctivitis, Subcutaneous Immunotherapy (SCIT), Allergovac Poliplus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen Immunotherapy (AIT)Also: Allergovac PoliplusImmunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation | Biological | – |
Primary outcome
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
5 secondary outcomes
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: Basal-12 months
Total number, percentage, severity and gradation of adverse reactions
Time frame: Basal- 6 months-12 months
Patient´s Tolerability assessment using a Likert-type scale
Time frame: 6 months-12 months
Patient's perception of the improvement in their global status using a Likert-type scale
Time frame: 12 months
Patient's Satisfaction using a Likert scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Rhinitis, Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Rhinoconjunctivitis, run by Roxall Medicina España S.A at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Symptoms and Medication Score (CSMS) (time frame: Basal-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.