Primary DiseasePhase 3NCT00803244
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
A Phase 3 study testing 300 IR in people with Primary Disease, run by Stallergenes Greer at 6 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Primary Disease
- What is being tested?
- 300 IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jan 2009to Jan 2010
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female outpatients aged 12 to 65 years (inclusive).
- Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
- Positive SPT
- RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.
Who cannot join
- Positive SPT to any other seasonal allergens present during the grass pollen season
- Patients with clinically significant confounding symptoms of allergy to other allergens
- Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France3 sites
Stallergenes Sa
Antony, 92183
Hop Montauban
Montauban
Cab medical
Orange
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Read the detailed description
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
- The Average Adjusted Symptom Score (AASS).
To document the safety of the treatment.
- Conditions
- Primary Disease
- Being tested
- 300 IR, Placebo
- Keywords
- allergic rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 IRDrug
Also called Sublingual immunotherapy tablet
300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season
PlaceboDrug
Also called Sublingual placebo tablet
Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season
| Study group | Role | What they receive |
|---|---|---|
| 300 IR | Experimental | 300 IR grass pollen allergen extract tablet Receives: Drug: 300 IR |
| Placebo | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Adjusted Symptom Score (AAdSS)
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.
Participants assessed daily, during the pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.
Measured: Pollen period (average of 32.1 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionJan 2010
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.
- Other trials for Primary DiseaseStudies 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
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DE BLAY Frédéric, MD, Principal investigator, NHC, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803244
- Sponsor's protocol ID
- VO60.08
- Status last verified
- Apr 2016
- First submitted
- 27 Nov 2008
- Last updated
- 25 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 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, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00803244
- Acronym / sponsor ID
- VO60.08
- Conditions
- Primary Disease
- Keywords
- allergic rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 25 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Detailed description
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
- The Average Adjusted Symptom Score (AASS).
To document the safety of the treatment.
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 IR300 IR grass pollen allergen extract tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients aged 12 to 65 years (inclusive).
- Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
- Positive SPT
- RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.
Key exclusion criteria (4 listed)
- Positive SPT to any other seasonal allergens present during the grass pollen season
- Patients with clinically significant confounding symptoms of allergy to other allergens
- Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).
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 IRAlso: Sublingual immunotherapy tablet300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season | Drug | 300 IR |
| PlaceboAlso: Sublingual placebo tabletPlacebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season | Drug | Placebo |
Primary outcome
Average Adjusted Symptom Score (AAdSS)
Time frame: Pollen period (average of 32.1 days)
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 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 25 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
DE BLAY Frédéric, MD principal investigator
NHC, Hôpitaux Universitaires de Strasbourg
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 300 IR in people with Primary Disease, run by Stallergenes Greer at 6 sites in 3 countries.
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 4 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 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Spain, Italy. 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 25 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 Adjusted Symptom Score (AAdSS) (time frame: Pollen period (average of 32.1 days)). 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 2016.