Rhinoconjunctivitis With or Without Allergic AsthmaNCT03963947
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
An observational study of Rhinoconjunctivitis With or Without Allergic Asthma, run by Alfons Malet i Casajuana at 1 site in Spain.
Trial summary
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Rhinoconjunctivitis With or Without Allergic Asthma
- What is being tested?
- Beltavac® Polymerized with house dust mites
- How many people
- 97 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 24 May 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis associated with or not with asthma caused by house dust mites
Who may be able to join
- Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- Positive skin testing
- Positive Serum-Specific IgE determination
- Parental or legal representative informed consent
- Clinical sintomatology on the inclusion period
Who cannot join
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from uncontrolled and severe 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
1 site in 1 country.
About this study
Official title: Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients
Read the detailed description
This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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 house dust mites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beltavac® Polymerized with house dust mitesBiological
Adminstration of Beltavac® Polymerized with house dust mites 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
Measured: 1 Year
Secondary outcomes (4)
Combined symtom 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: 1 Year
Combined symtom 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: 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
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 posted28 May 2019
- Study start1 Jun 2019
- Primary completion24 May 2023
- Study completion24 May 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfons Malet i Casajuana
- Sponsor type
- University, hospital or other
- Collaborators
- Probelte Pharma S.L.U.
- Responsible party
- Sponsor-investigator, Alfons Malet i Casajuana, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963947
- Sponsor's protocol ID
- MAL-BEL-2018-01
- Status last verified
- May 2023
- First submitted
- 23 May 2019
- Last updated
- 25 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 25 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 of Beltavac® Polymerized With House Dust Mites
- ClinicalTrials.gov ID
- NCT03963947
- Acronym / sponsor ID
- MAL-BEL-2018-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Alfons Malet i CasajuanaUniversity, hospital or other
- Collaborators
- Probelte Pharma S.L.U.
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 28 May 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® Polymerised With House Dust Mite in pediatric allergic patients
Detailed description
This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis associated with or not with asthma caused by house dust mites
Key inclusion criteria (5 listed)
- Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- Positive skin testing
- Positive Serum-Specific IgE determination
- Parental or legal representative informed consent
- Clinical sintomatology on the inclusion period
Key exclusion criteria (8 listed)
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from uncontrolled and severe 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 house dust mitesAdminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice | Biological | – |
Primary outcome
Numbers of treatment-related local and systemic reactions
Time frame: 1 Year
4 secondary outcomes
Combined symtom and medication score of Rhinoconjunctivitis
Time frame: 1 Year
Combined symtom and medication score of Asthma
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 25 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Alfons Malet i Casajuana at 1 site 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 5 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 25 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 1 site 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 25 May 2023.