HypersensitivityPhase 3NCT01731249
Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
A Phase 3 study testing Birch pollen allergen extract in people with Hypersensitivity and Allergic Rhinitis, run by Stallergenes Greer at 11 sites in 11 countries.
Trial summary
The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypersensitivity, Allergic Rhinitis, Allergic Conjunctivitis
- What is being tested?
- Birch pollen allergen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 574 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Nov 2010to Oct 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
- Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter > 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
- RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
- Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
- Patients who are willing to comply with the protocol.
- Patients having given a signed informed consent before completing any study related procedure.
Who cannot join
- Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
- Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
- Patients with ongoing treatment by immunotherapy with another allergen.
- Pregnancy (positive pregnancy test), breast-feeding.
- Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
- Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
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- Patients with moderate or severe persistent asthma (GINA 3 or 4).
- Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
- Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
- Patients with severe immune deficiency.
- Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
- Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
- Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
- Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
- Patients under continuous corticotherapy (inhaled or systemic drugs).
- Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
- Investigators, co-Investigators, as well as their children or spouses and all study collaborators.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
Denmark1 site
National University Hospital - Allergy Unit 4222
Copenhagen, 2100
Germany1 site
Universitätsmedizin Berlin - Allergie-Centrum-Charité
Berlin, 10117
Latvia1 site
Centre of Investigations and Treatment of Allergic Diseases
Riga, 1003
Lithuania1 site
Allergic Diseases Diagnostics and Treatment Centre
Vilnius, 08109
Poland1 site
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, 90-153
Sweden1 site
Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi
Gothenburg, 413 45
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.
- Being tested
- Placebo, Birch pollen allergen extract
- Keywords
- Sublingual immunotherapy, Birch pollen extract solution, Allergic rhinoconjunctivitis
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic, Conjunctivitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years
Birch pollen allergen extractBiological
Also called Staloral Birch
Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo sublingual solution Receives: Biological: Placebo |
| Birch pollen allergen extract | Experimental | Sublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years Receives: Biological: Birch pollen allergen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Adjusted Symptom Score
Symptom score adjusted on patient's rescue medication usage
Measured: Year 2 of treatment
Secondary outcomes (19)
Average Rhinoconjunctivitis Total Symptom Score
Measured: Year 2 of treatment
Average Rescue Medication Score
Measured: Year 2 of treatment
Each of Six Individual Average Rhinoconjunctivitis Symptom Scores
Measured: Year 2 of treatment
Average Combined Score
Measured: Year 2 of treatment
Average Rhinoconjunctivitis Visual Analogue Scale Score
Measured: Year 2 of treatment
Average Adjusted Visual Analogue Scale Score
Measured: Year 2 of treatment
Rescue Medication Usage
Measured: Year 2 of treatment
Proportion of Symptom-controlled Days
Measured: Year 2 of treatment
Rhinoconjunctivitis Quality of Life Questionnaire
Measured: Year 2 of treatment
Global evaluation of the efficacy by the patient
Measured: Year 2 of treatment
Sensitization profile
sensitization profile (mono- vs poly-sensitized) is derived from the skin prick test results
Measured: Before and after each treatment period (over 2 years)
Asthma
Measured: Before, during and after each pollen season (over 2 years)
Immunological markers specific for birch pollen
Measured: Before and after each treatment period (over 2 years)
Economical Evaluation
Proportion of days-off due to birch pollen-induced symptoms
Measured: Year 2 of treatment
Wheal diameter of the birch allergen Skin prick test
Measured: Before and after each treatment period (over 2 years)
Oral Provocation Test
Analysis on a subset of patients presenting an Oral Allergy Syndrome at study entry
Measured: Year 2 of treatment
Mucosa Local Inflammation
Analysis on a subset of patients
Measured: Year 1 of treatment
Safety assessments
adverse events, physical examination including vital signs and laboratory data described by number of patients in each treatment group
Measured: ~20 months
Average adjusted Symptom score analysis by tertiles
Measured: Year 2 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionOct 2012
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 HypersensitivityStudies 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
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Aptuit, Cenduit LLC, PHT Corporation
- Responsible party
- Sponsor
- Investigators
- Margitta WORM, MD, PR, Principal investigator, Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731249
- Sponsor's protocol ID
- VO68.10
- Other IDs
- 2010-020693-42
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy. 2014 Feb 11;4(1):7. doi: 10.1186/2045-7022-4-7.
PubMed 24517417
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01731249
- Acronym / sponsor ID
- VO68.10
- Keywords
- Sublingual immunotherapy, Birch pollen extract solution, Allergic rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Aptuit, Cenduit LLC, PHT Corporation
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Nov 2012 (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.
The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo sublingual solution |
| Birch pollen allergen extract | Experimental | Biological: Birch pollen allergen extractSublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
- Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter > 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
- RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
- Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
- Patients who are willing to comply with the protocol.
Key exclusion criteria (17 listed)
- Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
- Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
- Patients with ongoing treatment by immunotherapy with another allergen.
- Pregnancy (positive pregnancy test), breast-feeding.
- Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
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 |
|---|---|---|
| Placebo10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years | Biological | Placebo |
| Birch pollen allergen extractAlso: Staloral BirchSublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years | Biological | Birch pollen allergen extract |
Primary outcome
Average Adjusted Symptom Score
Time frame: Year 2 of treatment
Symptom score adjusted on patient's rescue medication usage
19 secondary outcomes
Average Rhinoconjunctivitis Total Symptom Score
Time frame: Year 2 of treatment
Average Rescue Medication Score
Time frame: Year 2 of treatment
Each of Six Individual Average Rhinoconjunctivitis Symptom Scores
Time frame: Year 2 of treatment
Average Combined Score
Time frame: Year 2 of treatment
Average Rhinoconjunctivitis Visual Analogue Scale Score
Time frame: Year 2 of treatment
Average Adjusted Visual Analogue Scale Score
Time frame: Year 2 of treatment
Rescue Medication Usage
Time frame: Year 2 of treatment
Proportion of Symptom-controlled Days
Time frame: Year 2 of treatment
Rhinoconjunctivitis Quality of Life Questionnaire
Time frame: Year 2 of treatment
Global evaluation of the efficacy by the patient
Time frame: Year 2 of treatment
Sensitization profile
Time frame: Before and after each treatment period (over 2 years)
Asthma
Time frame: Before, during and after each pollen season (over 2 years)
Immunological markers specific for birch pollen
Time frame: Before and after each treatment period (over 2 years)
Economical Evaluation
Time frame: Year 2 of treatment
Wheal diameter of the birch allergen Skin prick test
Time frame: Before and after each treatment period (over 2 years)
Oral Provocation Test
Time frame: Year 2 of treatment
Mucosa Local Inflammation
Time frame: Year 1 of treatment
Safety assessments
Time frame: ~20 months
Average adjusted Symptom score analysis by tertiles
Time frame: Year 2 of treatment
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 27 Nov 2012.
- Derived from this study: PubMed 24517417Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy. 2014 Feb 11;4(1):7. doi: 10.1186/2045-7022-4-7.
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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.
Margitta WORM, MD, PR principal investigator
Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Birch pollen allergen extract in people with Hypersensitivity and Allergic Rhinitis, run by Stallergenes Greer at 11 sites in 11 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 6 inclusion and 17 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia, Denmark, Estonia, Finland, France and 6 more countries. 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?
Average Adjusted Symptom Score (time frame: Year 2 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 NCT01731249, 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 27 Nov 2012.