Rhinoconjunctivitis With or Without Allergic AsthmaNCT03604718
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata
An observational study of Rhinoconjunctivitis With or Without Allergic Asthma, run by Probelte Pharma S.L.U. at 13 sites in Spain.
Trial summary
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Rhinoconjunctivitis With or Without Allergic Asthma
- What is being tested?
- Beltavac® Polymerized with Alternaria alternata
- How many people
- 65 participants
- Where
- 13 sitesSpain
- Study dates
- 7 Jun 2018to 20 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata
Who may be able to join
- Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
- Positive skin testing or IgE determination to the relevant allergen
Who cannot join
- Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Medical Center Fedear
Barcelona, Catalonia
Allergo Centre
Barcelona
Medical Center Cenvi Medic
Barcelona
University Hospital of Cartagena
Cartagena, Murcia
Alergomundo
Madrid
Clinica Torrelodones
Madrid
Ojeda Clinic
Madrid
University Hospital Virgen de la Arrixaca
Murcia, 30100
Reina Sofia Universitary Hospital
Murcia
Clínica de Alergia Mar Jiménez Lara
Talavera de la Reina, Toledo
Clinica Alergologica Dr Moral
Toledo
University Hospital of Torrejon
Torrejón de Ardoz, Madrid
Universitary Hospital of Vic
Vic, Barcelona
About this study
Official title: Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients
Read the detailed description
This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.
Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.
- Being tested
- Beltavac® Polymerized with Alternaria alternata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beltavac® Polymerized with Alternaria alternataBiological
Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of treatment-related local and systemic reactions
Number of adverse reactions occurred during the treatment period and classified according to the WAO standard
Measured: 1 year
Secondary outcomes (3)
Rhinoconjuntivitis medication intake
Medication intake for allergy symptons control at baseline, 6 and 12 months
Measured: 1 year
Visual analogue Scale Score
Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms"
Measured: 1 year
IgE and IgG4 specific quantification
IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start7 Jun 2018
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinoconjunctivitis With or Without Allergic AsthmaStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probelte Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Inmaculada Buendía Jiménez, Study director, Probelte Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604718
- Sponsor's protocol ID
- PRO-POL-2017-01
- Other IDs
- PRO-BEL-2017-01
- Status last verified
- May 2023
- First submitted
- 19 Jul 2018
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata
- ClinicalTrials.gov ID
- NCT03604718
- Acronym / sponsor ID
- PRO-POL-2017-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Probelte Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 27 Jul 2018 (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.
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients
Detailed description
This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.
Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata
Key inclusion criteria (2 listed)
- Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
- Positive skin testing or IgE determination to the relevant allergen
Key exclusion criteria (1 listed)
- Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline
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 |
|---|---|---|
| Beltavac® Polymerized with Alternaria alternataAdminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice | Biological | – |
Primary outcome
Numbers of treatment-related local and systemic reactions
Time frame: 1 year
Number of adverse reactions occurred during the treatment period and classified according to the WAO standard
3 secondary outcomes
Rhinoconjuntivitis medication intake
Time frame: 1 year
Visual analogue Scale Score
Time frame: 1 year
IgE and IgG4 specific quantification
Time frame: 1 year
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 11 May 2023.
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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.
Inmaculada Buendía Jiménez study director
Probelte Pharma
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoconjunctivitis With or Without Allergic Asthma, run by Probelte Pharma S.L.U. at 13 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 2 inclusion and 1 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Numbers of treatment-related local and systemic reactions (time frame: 1 year). 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 11 May 2023.