Allergic RhinoconjunctivitisPhase 3NCT00841256
Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
A Phase 3 study testing Grass pollen allergens in a water/glycerol solution in people with Allergic Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Grass pollen allergens in a water/glycerol solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Aug 2015
- Phase
- Phase 3
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4 - <12 years (at the time of inclusion)
- Positive SPT
- Positive EAST
- Positive CPT
Who cannot join
- Serious chronic diseases
- Other perennial allergies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Paediatrie Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
About this study
Official title: ... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.
Read the detailed description
Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Grass pollen allergens in a water/glycerol solution, Placebo
- Keywords
- specific immunotherapy, SIT, SLIT, sublingual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen allergens in a water/glycerol solutionBiological
Also called Allerslit forte grasses
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
PlaceboDrug
Also called Comparator
Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Experimental | Grass pollen allergens in a water/glycerol solution Receives: Biological: Grass pollen allergens in a water/glycerol solution |
| Placebo | Placebo comparator | Water/glycerol solution with phosphate buffered saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Symptom-Medication-Score
The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.
Measured: After 1 year of treatment
Secondary outcomes (1)
Evaluation of the documentation of adverse events (AEs)
Safety of treatments during the entire treatment period.
Measured: Entire treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2012
- Study completionAug 2015
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 Allergic RhinoconjunctivitisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Wahn, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841256
- Sponsor's protocol ID
- AL0506st
- Other IDs
- 2006-005911-82
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2008
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.
PubMed 22939758
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
- ClinicalTrials.gov ID
- NCT00841256
- Acronym / sponsor ID
- AL0506st
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- specific immunotherapy, SIT, SLIT, sublingual
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Feb 2009 (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.
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.
Detailed description
Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Experimental | Biological: Grass pollen allergens in a water/glycerol solutionGrass pollen allergens in a water/glycerol solution |
| Placebo | Placebo comparator | Drug: PlaceboWater/glycerol solution with phosphate buffered saline |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 4 - <12 years (at the time of inclusion)
- Positive SPT
- Positive EAST
- Positive CPT
Key exclusion criteria (2 listed)
- Serious chronic diseases
- Other perennial allergies
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 |
|---|---|---|
| Grass pollen allergens in a water/glycerol solutionAlso: Allerslit forte grassesIn total up to 4 drops (dose for maintenance therapy) are administered under the tongue. | Biological | Immunotherapy |
| PlaceboAlso: ComparatorPlacebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season. | Drug | Placebo |
Primary outcome
Changes of Symptom-Medication-Score
Time frame: After 1 year of treatment
The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.
1 secondary outcome
Evaluation of the documentation of adverse events (AEs)
Time frame: Entire treatment period
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 16 Oct 2015.
- Results publication: PubMed 22939758Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.
- Leader in specific allergy research and therapyLink provided by the sponsor.
- Click here for information about this trial in the European Clinical Trials RegisterLink provided by the sponsor.
Related trials for Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
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.
Ulrich Wahn, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grass pollen allergens in a water/glycerol solution in people with Allergic Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG 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 4 inclusion and 2 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 16 Oct 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes of Symptom-Medication-Score (time frame: After 1 year of treatment). 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 NCT00841256, 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 16 Oct 2015.