AllergyPhase 3NCT00310466

Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

A Phase 3 study testing Sublingual immunotherapy in people with Allergy, run by ALK-Abelló A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Allergy
What is being tested?: Sublingual immunotherapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 226 participants
Where: 1 siteGermany
Study dates: Jun 2005to Jan 2007
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

A history of birch pollen allergy
Positive skin prick test to birch
Positive conjunctival test to birch
Positive specific Immunoglobulin E (IgE) to birch

Who cannot join

Forced expiratory volume in 1 second (FEV1)<70% of predicted value
History of seasonal allergy interfering with study
History of symptomatic perennial allergy
History of emergency visit or admission for asthma in the previous 12 month

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, State of Berlin, D-10117

Other trials in Germany

About this study

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Read the detailed description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Conditions: Allergy
Being tested: Sublingual immunotherapy, Placebo
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sublingual immunotherapyBiological
Also called SLITone(TM) Birch
once daily intake of sublingual drops
PlaceboBiological
once daily intake of sublingual drops

Study groups in NCT00310466
Study group	Role	What they receive
Sublingual immunotherapy	Active comparator	sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose) Receives: Biological: Sublingual immunotherapy
Placebo	Placebo comparator	placebo sublingual drops Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Rhinoconjunctivitis Symptom Score
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Measured: Birch pollen season 2006
Daily Rhinoconjunctivitis Rescue Medication Score
Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).
Measured: Birch pollen season 2006

Secondary outcomes (2)

Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).
Measured: Birch pollen season 2006
Adverse Events
An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).
Measured: Birch pollen season 2006

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jan 2007

First posted4 Apr 2006 (estimated)
Study startJun 2005
Primary completionAug 2006
Study completionJan 2007

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 AllergyStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310466
Sponsor's protocol ID: SHX0712
Status last verified: Apr 2013
First submitted: 2 Apr 2006
Last updated: 14 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis
ClinicalTrials.gov ID: NCT00310466
Acronym / sponsor ID: SHX0712
Conditions: Allergy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: ALK-Abelló A/SIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Aug 2006 (actual)
Study completion: Jan 2007 (actual)
First posted: 4 Apr 2006 (estimated)
Results: Posted 6 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Detailed description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sublingual immunotherapy	Active comparator	Biological: Sublingual immunotherapysublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Placebo	Placebo comparator	Biological: Placeboplacebo sublingual drops

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

A history of birch pollen allergy
Positive skin prick test to birch
Positive conjunctival test to birch
Positive specific Immunoglobulin E (IgE) to birch

Key exclusion criteria (4 listed)

Forced expiratory volume in 1 second (FEV1)<70% of predicted value
History of seasonal allergy interfering with study
History of symptomatic perennial allergy
History of emergency visit or admission for asthma in the previous 12 month

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
Sublingual immunotherapyAlso: SLITone(TM) Birchonce daily intake of sublingual drops	Biological	Sublingual immunotherapy
Placeboonce daily intake of sublingual drops	Biological	Placebo

Primary outcome

Daily Rhinoconjunctivitis Symptom Score
Time frame: Birch pollen season 2006
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Daily Rhinoconjunctivitis Rescue Medication Score
Time frame: Birch pollen season 2006
Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).

2 secondary outcomes

Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
Time frame: Birch pollen season 2006
Adverse Events
Time frame: Birch pollen season 2006

Results and safety

Results posted to the registry on 6 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SLITone Birch	113	95
Placebo	113	101

Primary outcome: Daily Rhinoconjunctivitis Symptom Score

Time frame: Birch pollen season 2006. Mean (Standard Deviation). Unit: Units on a scale (0-18)

Measure	SLITone Birch n = 95	Placebo n = 101
Value	4.07 (2.59)	4.14 (2.56)

SLITone Birch vs Placebo: p = 0.87, ANOVA

Primary outcome: Daily Rhinoconjunctivitis Rescue Medication Score

Time frame: Birch pollen season 2006. Mean (Standard Deviation). Unit: Units on a scale (0-30)

Measure	SLITone Birch n = 95	Placebo n = 101
Value	2.76 (3.30)	2.54 (2.99)

SLITone Birch vs Placebo: p = 0.55, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SLITone Birch	4 of 113 (3.5%)	81 of 113 (71.7%)	Not reported
Placebo	2 of 113 (1.8%)	87 of 113 (77%)	Not reported

Limitations and caveats (from the sponsor): Clinical improvement following SLIT is thought to be due to immunological mechanisms that develop over time. Even though clear immunological changes were observed in this trial it appears that the treatment was too short to reach full clinical effect

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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Asthma
RecruitingObservational study
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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.

Hendrik Wolf, PhD study director

ALK-SCHERAX Arzneimittel GmbH

Margitta Worm, MD, Prof. principal investigator

Charite University, Berlin, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sublingual immunotherapy in people with Allergy, run by ALK-Abelló A/S 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 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 14 May 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. 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 6 Aug 2009). 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?

Daily Rhinoconjunctivitis Symptom Score (time frame: Birch pollen season 2006). The study lists 2 primary outcomes in all. 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 NCT00310466.

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 14 May 2013.