AllergyPhase 2/3NCT00367640

Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

A Phase 2/3 study testing 100 IR grass pollen allergen extract tablet, 300 IR grass pollen allergen extract tablet and 500 IR grass pollen allergen extract tablet in people with Allergy, run by Stallergenes Greer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Allergy
What is being tested?: 100 IR grass pollen allergen extract tablet, 300 IR grass pollen allergen extract tablet and 500 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: 628 participants
Where: No sites listed yet
Study dates: Nov 2004to Sep 2005
Phase: Phase 2/3
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 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Written consent
Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
Safety laboratory resuts within the references ranges

Who cannot join

Pregnancy, breast-feeding/lactation
Had received desensitisation treatment for grass pollen
Treatment by immunotherapy with another allergen within the previous 5 years
Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
Treated with beta-blockers or under continuous corticotherapy

About this study

Official title: Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Conditions: Allergy
Being tested: 100 IR grass pollen allergen extract tablet, 300 IR grass pollen allergen extract tablet, 500 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.

100 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
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
500 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 groups in NCT00367640
Study group	Role	What they receive
100 IR	Experimental	100 IR grass pollen allergen extract tablet Receives: Drug: 100 IR grass pollen allergen extract tablet
300 IR	Experimental	300 IR grass pollen allergen extract tablet Receives: Drug: 300 IR grass pollen allergen extract tablet
500 IR	Experimental	500 IR grass pollen allergen extract tablet Receives: Drug: 500 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
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 32 days in the ITT set)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Sep 2005

First posted23 Aug 2006 (estimated)
Study startNov 2004
Primary completionSep 2005
Study completionSep 2005

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00367640
Sponsor's protocol ID: VO34.04
Status last verified: Apr 2016
First submitted: 22 Aug 2006
Last updated: 23 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.
PubMed 17935764

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
ClinicalTrials.gov ID: NCT00367640
Acronym / sponsor ID: VO34.04
Conditions: Allergy
Keywords: Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: Stallergenes GreerIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Sep 2005 (actual)
Study completion: Sep 2005 (actual)
First posted: 23 Aug 2006 (estimated)
Results: Posted 23 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
100 IR	Experimental	Drug: 100 IR grass pollen allergen extract tablet100 IR grass pollen allergen extract tablet
300 IR	Experimental	Drug: 300 IR grass pollen allergen extract tablet300 IR grass pollen allergen extract tablet
500 IR	Experimental	Drug: 500 IR grass pollen allergen extract tablet500 IR grass pollen allergen extract tablet
Placebo	Placebo comparator	Drug: Placebo tabletPlacebo tablet

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Written consent
Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
Safety laboratory resuts within the references ranges

Key exclusion criteria (5 listed)

Pregnancy, breast-feeding/lactation
Had received desensitisation treatment for grass pollen
Treatment by immunotherapy with another allergen within the previous 5 years
Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
Treated with beta-blockers or under continuous corticotherapy

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
100 IR grass pollen allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 4 months before pollen season and during pollen season	Drug	100 IR
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
500 IR grass pollen allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 4 months before pollen season and during pollen season	Drug	500 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
Time frame: Pollen period (average of 32 days in the ITT set)
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

Results posted to the registry on 23 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
100 IR	157	139
300 IR	155	133
500 IR	160	141
Placebo	156	146

Primary outcome: Average Rhinoconjunctivitis Total Symptom Score

Time frame: Pollen period (average of 32 days in the ITT set). Mean (Standard Deviation). Unit: Units on a scale (range: 0 to 18)

Measure	100 IR n = 142	300 IR n = 136	500 IR n = 143	Placebo n = 148
Value	4.72 (3.141)	3.58 (2.976)	3.74 (3.142)	4.93 (3.229)

500 IR vs Placebo: p = 0.0006, ANCOVA
300 IR vs Placebo: p = 0.0001, ANCOVA
100 IR vs Placebo: p = 0.4606, ANCOVA

Population analysed: The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.

Adverse events

Time frame: 4 months before the pollen period until the end of pollen period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
500 IR	3 of 160 (1.9%)	74 of 160 (46.3%)	Not reported
300 IR	1 of 155 (0.6%)	70 of 155 (45.2%)	Not reported
100 IR	0 of 157 (0%)	76 of 157 (48.4%)	Not reported
Placebo	0 of 156 (0%)	36 of 156 (23.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17935764Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.

Related trials for Allergy

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Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
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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.

Alain DIDIER, Professor principal investigator

Hôpital Rangueil-Larrey, Toulouse, France

Questions about this trial

What is this clinical trial studying?

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 5 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 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 (time frame: Pollen period (average of 32 days in the ITT set)). 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 NCT00367640, 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 23 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.