AllergyNCT02295969
Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis
An observational study of Allergy, run by Stallergenes Greer at 1 site in Germany.
Trial summary
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Allergy
- What is being tested?
- Oralair
- How many people
- 307 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to 3 Jul 2017
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Who may be able to join
- Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.
Who cannot join
- Patients already participating in a clinical trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Augsburg, Klinik für Kinder und Jugendliche
Augsburg, Bavaria, 86156
About this study
Official title: An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.
Read the detailed description
The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Patients are followed for safety and tolerability during the first 30 treatment days.
- Conditions
- Allergy
- Being tested
- Oralair
- Keywords
- Rhinitis, Conjunctivitis, Grass pollen, Sublingual tablet, Allergen immunotherapy, Safety
- Medical subject headings
- Hypersensitivity, Rhinitis, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OralairDrug
Observational study, Oralair is used as prescribed by the prescriber phycisian.
What is being measured
The primary outcome is the main question the study is designed to answer.
All adverse events that started on or after the day the first dose of Oralair
Measured: During 30 days after the date of the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Venn Life Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295969
- Sponsor's protocol ID
- SL74.14
- Status last verified
- Jul 2017
- First submitted
- 18 Nov 2014
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.
PubMed 31009701
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis
- ClinicalTrials.gov ID
- NCT02295969
- Acronym / sponsor ID
- SL74.14
- Conditions
- Allergy
- Keywords
- Rhinitis, Conjunctivitis, Grass pollen, Sublingual tablet, Allergen immunotherapy, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Venn Life Sciences
- Study start
- Dec 2014
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 20 Nov 2014 (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.
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.
Detailed description
The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Patients are followed for safety and tolerability during the first 30 treatment days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Key inclusion criteria (1 listed)
- Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.
Key exclusion criteria (1 listed)
- Patients already participating in a clinical trial.
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 |
|---|---|---|
| OralairObservational study, Oralair is used as prescribed by the prescriber phycisian. | Drug | – |
Primary outcome
All adverse events that started on or after the day the first dose of Oralair
Time frame: During 30 days after the date of the first 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 26 Jul 2017.
- Derived from this study: PubMed 31009701Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.
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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 Allergy, run by Stallergenes Greer at 1 site in Germany.
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 1 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 26 Jul 2017. 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 Germany. 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?
All adverse events that started on or after the day the first dose of Oralair (time frame: During 30 days after the date of the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295969, which also lists 1 linked publication.
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 26 Jul 2017.