Rhinoconjunctivitis With or Without Allergic AsthmaNCT04207697
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
An observational study of Rhinoconjunctivitis With or Without Allergic Asthma, run by Probelte Pharma S.L.U. at 7 sites in Spain.
Trial summary
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander in allergic patients Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis With or Without Allergic Asthma
- What is being tested?
- Beltavac® Polymerized with cat dander
- How many people
- 34 participants
- Where
- 7 sitesSpain
- Study dates
- 1 Dec 2019to 9 Feb 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander
Who may be able to join
- Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- Positive skin testing
- Positive Serum-Specific IgE determination
- Informed consent
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
- Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
- Patients with immunotherapy treatment at the time of inclusion
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Al-lergo Centre Clinic
Barcelona
Bellvitge University Hospital
Barcelona
Campus de la Salud University Hospital
Granada, Andalusia
Alergogranada
Granada
Ciudad de Jaen Hospital
Jaén, Andalusia
Quirón Malaga Hospital
Málaga, Malaga
Quirón Campo de Gibraltar Hospital
Palmones, Cádiz
About this study
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander 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 with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.
- Being tested
- Beltavac® Polymerized with cat dander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beltavac® Polymerized with cat danderBiological
Adminstration of Beltavac® Polymerized with cat dander 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 standards
Measured: 12 months
Secondary outcomes (4)
Combined Symptom and Medication Score of Rhinoconjunctivitis
The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)
Measured: 12 months
Combined Symptom and Medication Score of Asthma
The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)
Measured: 12 months
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: 12 months
IgE and IgG4 specific quantification
IgE and IgG4 quantification in serum at baseline, 6 and 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Dec 2019
- Primary completion9 Feb 2023
- Study completion9 Feb 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probelte Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolina Mérida, Principal investigator, San Cecilio Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207697
- Sponsor's protocol ID
- PRO-BEL-2019-01
- Status last verified
- May 2023
- First submitted
- 19 Dec 2019
- 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
- Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
- ClinicalTrials.gov ID
- NCT04207697
- Acronym / sponsor ID
- PRO-BEL-2019-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Probelte Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 23 Dec 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.
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander 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 with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 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
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander
Key inclusion criteria (4 listed)
- Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- Positive skin testing
- Positive Serum-Specific IgE determination
- Informed consent
Key exclusion criteria (8 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
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 cat danderAdminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice | Biological | – |
Primary outcome
Numbers of treatment-related local and systemic reactions
Time frame: 12 months
Number of adverse reactions occurred during the treatment period and classified according to the WAO standards
4 secondary outcomes
Combined Symptom and Medication Score of Rhinoconjunctivitis
Time frame: 12 months
Combined Symptom and Medication Score of Asthma
Time frame: 12 months
Visual analogue Scale Score
Time frame: 12 months
IgE and IgG4 specific quantification
Time frame: 6 and 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 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.
Carolina Mérida principal investigator
San Cecilio Universitary Hospital
7 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 7 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 4 inclusion and 8 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 7 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: 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 11 May 2023.