RhinoconjunctivitisPhase 2NCT00818181
Open Label Safety Study of a Birch Pollen Allergen Extract
A Phase 2 study testing Biological: AL0206st in people with Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
This trial is performed to assess safety of a sublingual birch pollen extract. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- Biological: AL0206st
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Aug 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Allergic rhinoconjunctivitis attributable to birch pollen
- Positive SPT
- Positive EAST
Who cannot join
- Serious chronic diseases
- Other perennial allergies
- Partly controlled asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy
This trial is performed to assess safety of a sublingual birch pollen extract.
- Conditions
- Rhinoconjunctivitis
- Being tested
- Biological: AL0206st
- Keywords
- Type I - Allergy, rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: AL0206stDrug
| Study group | Role | What they receive |
|---|---|---|
| Solution of birch pollen allergen extract | Experimental | In total up to 4 drops (dose for maintainace therapy)are administered under the tongue. Receives: Drug: Biological: AL0206st |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with at least one adverse event
Between Visit 03 and Visit 05 (June 2008 - January 2009)
Measured: 8 months
Secondary outcomes (1)
Systemic reactions
The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.
Measured: Entire treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Hunzelmann, Prof. Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818181
- Sponsor's protocol ID
- AL0206st
- Other IDs
- 2007-006053-24
- Status last verified
- Mar 2013
- First submitted
- 6 Jan 2009
- Last updated
- 11 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT00818181
- Acronym / sponsor ID
- AL0206st
- Conditions
- Rhinoconjunctivitis
- Keywords
- Type I - Allergy, rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Jan 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.
This trial is performed to assess safety of a sublingual birch pollen extract.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solution of birch pollen allergen extract | Experimental | Drug: Biological: AL0206stIn total up to 4 drops (dose for maintainace therapy)are administered under the tongue. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Allergic rhinoconjunctivitis attributable to birch pollen
- Positive SPT
- Positive EAST
Key exclusion criteria (3 listed)
- Serious chronic diseases
- Other perennial allergies
- Partly controlled asthma
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 |
|---|---|---|
| Biological: AL0206st | Drug | Solution of birch pollen allergen extract |
Primary outcome
number of patients with at least one adverse event
Time frame: 8 months
Between Visit 03 and Visit 05 (June 2008 - January 2009)
1 secondary outcome
Systemic reactions
Time frame: Entire treatment period
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 11 Mar 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
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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.
Nicolas Hunzelmann, Prof. Dr. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological: AL0206st in people with Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
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 3 inclusion and 3 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 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
number of patients with at least one adverse event (time frame: 8 months). 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 11 Mar 2013.