Allergic RhinitisAPOLONCT02844842
Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
An observational study of Allergic Rhinitis and Rhinoconjunctivitis, run by Roxall Medicina España S.A at 15 sites in Spain.
Trial summary
This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is… Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Allergic Rhinitis, Rhinoconjunctivitis, Asthma
- What is being tested?
- Allergovac Poliplus
- How many people
- 152 participants
- Where
- 15 sitesSpain
- Study dates
- 23 Nov 2016to 6 Sep 2018
- 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: Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma
Who may be able to join
- Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.
- Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.
- Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.
Who cannot join
- Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.
- Patients that according to the investigator may present difficulties to complete the patient diary.
- Patients who are participating in another clinical trial or observational study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
C.H.U A Coruña
A Coruña
Hopsital de Vinalopó
Elche
Clínica Dr. Arias Irigoyen
Huelva
Clínica Dra. Victoria Moreno
Huelva
Hospital de Lugo
Lugo
Clínica de Asma y Alergia Dres. Ojeda
Madrid
Hospital Principe de Asturias
Madrid
Hospital Puerta de Hierro
Madrid
Hospital de Onteniente
Ontinyent
Hospital de Tórax
Santa Cruz de Tenerife
Hospital Ntra. Sra de la Candelaria
Santa Cruz de Tenerife
Hospital Joan XXIII
Tarragona
Hospital de Terrassa
Terrassa
Hospital de Manises
Valencia
Hospital de Xátiva
Xátiva
About this study
This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.
The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis, Asthma
- Being tested
- Allergovac Poliplus
- Keywords
- mild or moderate
- Medical subject headings
- Rhinitis, Allergic, Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovac PoliplusBiological
| Study group | Role | What they receive |
|---|---|---|
| 1 day initiation schedule | The initiation Schedule consists in administering 0.2 mL and 0.3 mL with 30 minutes of interval in the same day. Thus, the patient will reach the maintenance dose of 0.5 mL in one day. Receives: Biological: Allergovac Poliplus | |
| Rapid initiation schedule | The patient will receive 3 increasing doses (0.1 mL + 0.3mL + 0.5 mL) weekly doses till the maintenance dose (0.5 mL) is reached. Receives: Biological: Allergovac Poliplus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse drug reactions
Measured: From patient ICF signature till 1 week after last administered dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start23 Nov 2016
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- 152 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
- NCT02844842
- Sponsor's protocol ID
- BIA-ALE-2016-01
- Acronym
- APOLO
- Status last verified
- Jan 2019
- First submitted
- 22 Jul 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
- ClinicalTrials.gov ID
- NCT02844842
- Acronym / sponsor ID
- APOLO / BIA-ALE-2016-01
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis, Asthma
- Keywords
- mild or moderate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2016
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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 study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.
The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 day initiation schedule | – | Biological: Allergovac PoliplusThe initiation Schedule consists in administering 0.2 mL and 0.3 mL with 30 minutes of interval in the same day. Thus, the patient will reach the maintenance dose of 0.5 mL in one day. |
| Rapid initiation schedule | – | Biological: Allergovac PoliplusThe patient will receive 3 increasing doses (0.1 mL + 0.3mL + 0.5 mL) weekly doses till the maintenance dose (0.5 mL) is reached. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma
Key inclusion criteria (3 listed)
- Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.
- Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.
- Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.
Key exclusion criteria (3 listed)
- Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.
- Patients that according to the investigator may present difficulties to complete the patient diary.
- Patients who are participating in another clinical trial or observational study.
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 |
|---|---|---|
| Allergovac Poliplus | Biological | 1 day initiation schedule, Rapid initiation schedule |
Primary outcome
Number and severity of adverse drug reactions
Time frame: From patient ICF signature till 1 week after last administered dose
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 25 Jan 2019.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Rhinoconjunctivitis, run by Roxall Medicina España S.A at 15 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 3 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Number and severity of adverse drug reactions (time frame: From patient ICF signature till 1 week after last administered dose). 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 25 Jan 2019.