AllergyPhase 3ALLEGRA6NCT00623701
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
A Phase 3 study testing Allerslit forte in people with Allergy and Rhinitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Efficacy and Safety from a high-dosed sublingual grass pollen preparation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy, Rhinitis, Conjunctivitis
- What is being tested?
- Allerslit forte
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to 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
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation Test
Who cannot join
- Serious chronic disease
- other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
- Conditions
- Allergy, Rhinitis, Conjunctivitis
- Being tested
- Allerslit forte
- Keywords
- sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen
- Medical subject headings
- Hypersensitivity, Rhinitis, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allerslit forteBiological
sublingual placebo preparation, daily
Allerslit forteBiological
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | sublingual placebo preparation Receives: Biological: Allerslit forte |
| 2 | Experimental | Sublingual preparation, 40 micro grams Phl p 5 maintenance dose Receives: Biological: Allerslit forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and Medication Score
Measured: Grass pollen season 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristian Reich, Professor, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623701
- Sponsor's protocol ID
- AL0703st
- Other IDs
- 2007-000823-16
- Acronym
- ALLEGRA6
- Status last verified
- Nov 2013
- First submitted
- 19 Feb 2008
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
- ClinicalTrials.gov ID
- NCT00623701
- Acronym / sponsor ID
- ALLEGRA6 / AL0703st
- Conditions
- Allergy, Rhinitis, Conjunctivitis
- Keywords
- sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Feb 2008 (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.
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: Allerslit fortesublingual placebo preparation |
| 2 | Experimental | Biological: Allerslit forteSublingual preparation, 40 micro grams Phl p 5 maintenance dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation Test
Key exclusion criteria (2 listed)
- Serious chronic disease
- other perennial allergies
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 |
|---|---|---|
| Allerslit fortesublingual placebo preparation, daily | Biological | 1 |
| Allerslit forteSublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily | Biological | 2 |
Primary outcome
Symptom and Medication Score
Time frame: Grass pollen season 2009
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 8 Nov 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
- Click here for information about this trial in the European Clinical Trials RegisterLink 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.
Kristian Reich, Professor principal investigator
not affiliated
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 Allerslit forte in people with Allergy and Rhinitis, 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 4 inclusion and 2 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 8 Nov 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?
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?
Symptom and Medication Score (time frame: Grass pollen season 2009). 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 8 Nov 2013.