AllergyPhase 3NCT00409409
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
A Phase 3 study testing 300 IR grass pollen allergen extract tablet in people with Allergy, run by Stallergenes Greer at 1 site in Germany.
Trial summary
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Allergy
- What is being tested?
- 300 IR grass pollen allergen extract tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female outpatients aged 5 to 17 years.
- Written consent / assent.
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
- Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
Who cannot join
- Patients who have received any desensitisation treatment for grass pollen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
- Conditions
- Allergy
- Being tested
- 300 IR grass pollen allergen extract tablet, Placebo tablet
- Keywords
- Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 IR grass pollen allergen extract tabletDrug
Also called Sublingual immunotherapy tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Placebo tabletDrug
Also called Sublingual placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
| Study group | Role | What they receive |
|---|---|---|
| 300 IR | Experimental | 300 IR grass pollen allergen extract tablet Receives: Drug: 300 IR grass pollen allergen extract tablet |
| Placebo | Placebo comparator | Placebo tablet Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.
Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
Measured: Pollen period (average of 38.6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Wahn, Professor, Principal investigator, Charité - Campus Virchow Klinikum, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409409
- Sponsor's protocol ID
- VO52.06
- Status last verified
- Apr 2016
- First submitted
- 7 Dec 2006
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.
PubMed 19046761
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00409409
- Acronym / sponsor ID
- VO52.06
- Conditions
- Allergy
- Keywords
- Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
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 |
|---|---|---|
| 300 IR | Experimental | Drug: 300 IR grass pollen allergen extract tablet300 IR grass pollen allergen extract tablet |
| Placebo | Placebo comparator | Drug: Placebo tabletPlacebo tablet |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female outpatients aged 5 to 17 years.
- Written consent / assent.
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
- Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
Key exclusion criteria (1 listed)
- Patients who have received any desensitisation treatment for grass pollen.
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 |
|---|---|---|
| 300 IR grass pollen allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 4 months before pollen season and during pollen season | Drug | 300 IR |
| Placebo tabletAlso: Sublingual placebo tabletOne sublingual tablet daily during 4 months before pollen season and during pollen season | Drug | Placebo |
Primary outcome
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
Time frame: Pollen period (average of 38.6 days)
Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19046761Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.
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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.
Ulrich Wahn, Professor principal investigator
Charité - Campus Virchow Klinikum, 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 300 IR grass pollen allergen extract tablet in people with 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 5 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 May 2016. 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?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Rhinoconjunctivitis Total Symptom Score (ARTSS) (time frame: Pollen period (average of 38.6 days)). 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 NCT00409409, 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 May 2016.