Birch Pollen-related RhinoconjunctivitisPhase 2NCT00901914
Study of rBet v1 Tablets
A Phase 2 study testing rBet v 1 in people with Birch Pollen-related Rhinoconjunctivitis and Rhinitis, Allergic, Seasonal, run by Stallergenes Greer at 8 sites in 8 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Birch Pollen-related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal
- What is being tested?
- rBet v 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 483 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 2
- 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 last 2 pollen seasons
- Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
- Patients asymptomatic to all other allergens during the birch pollen season
- RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
- Patients with an FEV1 ≥ 80% of the predicted value
- Female patients with no childbearing potential
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- Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
- Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
- Patients having provided signed informed consent
Who cannot join
- Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
- Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
- 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
- Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
- Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
- Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polyposis or oral inflammation)
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- 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 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 local or systemic beta-blocker therapy and/or immunosuppressive drugs
- Patients with ongoing treatment by immunotherapy with another allergen
- Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or with long acting systemic corticosteroids 12 weeks before Screening
- Patients under continuous corticotherapy or undergoing chronic treatment with H2-antihistamine drugs
- Known hypersensitivity to mannitol
- Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method
- Patients with a history of drug or alcohol abuse
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Denmark1 site
National University Hospital - Allergy Unit 4222
Copenhagen, 2100
Lithuania1 site
Public Institution Kaunas Medical University Hospital
Kaunas, 50009
Poland1 site
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, 90-153
About this study
Official title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis
The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.
- Being tested
- Placebo, rBet v 1
- Keywords
- Hypersensitivity, Allergy, Birch, allergy, Sublingual Immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Also called Placebo control
One sublingual tablet of matching placebo daily during approximately 5.5 months
rBet v 1Biological
Also called rBet v 1.0101
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
rBet v 1Biological
Also called rBet v 1.0101
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
rBet v 1Biological
Also called rBet v 1.0101
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Biological: Placebo |
| 2 | Experimental | 12.5 µg rBet v 1 Receives: Biological: rBet v 1 |
| 3 | Experimental | 25 µg rBet v 1 Receives: Biological: rBet v 1 |
| 4 | Experimental | 50 µg rBet v 1 Receives: Biological: rBet v 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Adjusted Symptom Score
Measured: ~1 month (whole birch pollen season)
Secondary outcomes (9)
Average Rhinoconjunctivitis Total symptom Score
Measured: ~1 month (whole birch pollen season)
Rescue Medication Score
Measured: ~1 month (whole birch pollen season)
Average Combined Score
Measured: ~1 month (whole birch pollen season)
Proportion of symptom-controlled days
Measured: ~1 month (whole birch pollen season)
Global evaluation by the patient
Measured: after 5-6 months of treatment
Immunological markers (IgE and IgG4)
Measured: 6-7 months
Sensitisation status
Measured: At least 6 months
Lower airways symptoms
Measured: ~1 month (whole birch pollen season)
Safety assessments
Measured: 6-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen-related RhinoconjunctivitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Aptuit
- Investigators
- Sabina Rak, MD. PR, Principal investigator, Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901914
- Sponsor's protocol ID
- VO59.08
- Other IDs
- 2007-007869-21
- Status last verified
- Feb 2010
- First submitted
- 28 Apr 2009
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00901914
- Acronym / sponsor ID
- VO59.08
- Keywords
- Hypersensitivity, Allergy, Birch, allergy, Sublingual Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Aptuit
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 May 2009 (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 study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.
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 |
|---|---|---|
| 1 | Placebo comparator | Biological: PlaceboPlacebo |
| 2 | Experimental | Biological: rBet v 112.5 µg rBet v 1 |
| 3 | Experimental | Biological: rBet v 125 µg rBet v 1 |
| 4 | Experimental | Biological: rBet v 150 µg rBet v 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
- Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
- Patients asymptomatic to all other allergens during the birch pollen season
- RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
- Patients with an FEV1 ≥ 80% of the predicted value
Key exclusion criteria (15 listed)
- Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
- Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
- 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
- Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
- Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
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 |
|---|---|---|
| PlaceboAlso: Placebo controlOne sublingual tablet of matching placebo daily during approximately 5.5 months | Biological | 1 |
| rBet v 1Also: rBet v 1.0101One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months | Biological | 2 |
| rBet v 1Also: rBet v 1.0101One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months | Biological | 3 |
| rBet v 1Also: rBet v 1.0101One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months | Biological | 4 |
Primary outcome
Average Adjusted Symptom Score
Time frame: ~1 month (whole birch pollen season)
9 secondary outcomes
Average Rhinoconjunctivitis Total symptom Score
Time frame: ~1 month (whole birch pollen season)
Rescue Medication Score
Time frame: ~1 month (whole birch pollen season)
Average Combined Score
Time frame: ~1 month (whole birch pollen season)
Proportion of symptom-controlled days
Time frame: ~1 month (whole birch pollen season)
Global evaluation by the patient
Time frame: after 5-6 months of treatment
Immunological markers (IgE and IgG4)
Time frame: 6-7 months
Sensitisation status
Time frame: At least 6 months
Lower airways symptoms
Time frame: ~1 month (whole birch pollen season)
Safety assessments
Time frame: 6-7 months
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 Jun 2013.
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.
Sabina Rak, MD. PR principal investigator
Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rBet v 1 in people with Birch Pollen-related Rhinoconjunctivitis and Rhinitis, Allergic, Seasonal, run by Stallergenes Greer at 8 sites in 8 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 9 inclusion and 15 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 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Finland, France, Germany, Lithuania and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: ~1 month (whole birch pollen season)). 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 27 Jun 2013.