Allergic Rhinitis Due to Grass PollensPhase 3NCT00955825
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
A Phase 3 study testing 300 IR in people with Allergic Rhinitis Due to Grass Pollens, run by Stallergenes Greer at 19 sites in United States.
Trial summary
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollens
- 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
- 473 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2008to Aug 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Positive SPT to grasses
- Total symptoms score for the previous pollen season more than 12 out of 18.
- Patients with FEV1 ≥ 80% of the predicted value.
Who cannot join
- Positive SPT to other grasses present during the grass pollen season and if endemic to the region
- Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
- Asthma requiring treatment with medications other than beta-2 inhaled agonists.
- Patients who have received any desensitization treatment for grass pollen in the past 5 years.
- Ongoing immunotherapy with any other allergen.
- Patients with any nasal or oral condition that could confound the efficacy or safety assessments
Show all 16Show fewer
- Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
- Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study.
- Patients treated with systemic or inhaled corticosteroids
- Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
- Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above.
- Patients participating or having participated within 30 days before Screening in any clinical study.
- Patients who are unlikely to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which will compromise the data
- Patients with history of drug or alcohol abuse.
- Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study.
- Patients will not be randomized in this study more than once.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Montana Allergy & Asthma Specialists
Billings, Montana, 59101
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Clinical Research of the Ozarks, Inc.
Columbia, Missouri, 65203
Allergy and Asthma Research Group
Eugene, Oregon, 97401
Baker Allergy, Asthma, & Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
University of Kentucky Medical Center
Lexington, Kentucky, 40508
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, 97504
Montana Medical Research
Missoula, Montana, 59808
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Sneeze, wheeze, and Itch Associates, LLC
Normal, Illinois, 61761
Creighton University - Allergy & Asthma
Omaha, Nebraska, 68131
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Allergy Associates Research
Portland, Oregon, 97213
Midwest Clinical Research LLC
St Louis, Missouri, 63141
North West Asthma Allergy Center
Vancouver, Washington, 98664
Clinical Research of the Ozarks, Inc
Warrensburg, Missouri, 64093
Respiratory Medical Research Institute of Michigan PLC
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Read the detailed description
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population.
Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes.
Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications.
In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season.
Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- 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 taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
PlaceboDrug
Also called Sublingual placebo tablet
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over 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 | Pacebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Score (CS)
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.
The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).
The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
Measured: Pollen period (average of 42.8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
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 Allergic Rhinitis Due to Grass PollensStudies 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
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- COX Linda, MD, Principal investigator, Allergists and Immunologists - Fort Lauderdale - Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955825
- Sponsor's protocol ID
- VO61.08 USA
- Status last verified
- Apr 2016
- First submitted
- 3 Aug 2009
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, Melac M, Zeldin RK. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012 Dec;130(6):1327-34.e1. doi: 10.1016/j.jaci.2012.08.032. Epub 2012 Oct 31.
PubMed 23122534
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00955825
- Acronym / sponsor ID
- VO61.08 USA
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Keywords
- allergic rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 19 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 the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Detailed description
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population.
Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes.
Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications.
In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season.
Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.
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: PlaceboPacebo tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Positive SPT to grasses
- Total symptoms score for the previous pollen season more than 12 out of 18.
- Patients with FEV1 ≥ 80% of the predicted value.
Key exclusion criteria (16 listed)
- Positive SPT to other grasses present during the grass pollen season and if endemic to the region
- Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
- Asthma requiring treatment with medications other than beta-2 inhaled agonists.
- Patients who have received any desensitization treatment for grass pollen in the past 5 years.
- Ongoing immunotherapy with any other allergen.
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 taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season | Drug | 300 IR |
| PlaceboAlso: Sublingual placebo tabletPlacebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season | Drug | Placebo |
Primary outcome
Combined Score (CS)
Time frame: Pollen period (average of 42.8 days)
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. 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 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23122534Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, Melac M, Zeldin RK. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012 Dec;130(6):1327-34.e1. doi: 10.1016/j.jaci.2012.08.032. Epub 2012 Oct 31.
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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.
COX Linda, MD principal investigator
Allergists and Immunologists - Fort Lauderdale - Florida
19 sites 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 in people with Allergic Rhinitis Due to Grass Pollens, run by Stallergenes Greer at 19 sites in United States.
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 16 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 19 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 19 sites in United States. 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 19 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?
Combined Score (CS) (time frame: Pollen period (average of 42.8 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 NCT00955825, 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 19 May 2016.