Grass Pollen AllergyPhase 3NCT00264459
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
A Phase 3 study testing Grass pollen formulation and Comparator in people with Grass Pollen Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Grass Pollen Allergy
- What is being tested?
- Grass pollen formulation and Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2003to Sep 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,
Who cannot join
- Serious chronic diseases, Other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
- Conditions
- Grass Pollen Allergy
- Being tested
- Grass pollen formulation, Comparator
- Keywords
- Sublingual immunotherapy, Rhinoconjunctivitis, Rhinitis, Asthma
- Medical subject headings
- Rhinitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen formulationBiological
Also called specific immunotherapy
Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
ComparatorOther
Also called Specific Immunotherapy
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo was given the same way as a sublingual preparation. Receives: Other: Comparator |
| Liquid formulation of an extract of a 6 grass pollen mixture | Experimental | Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose. Receives: Biological: Grass pollen formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and Medication Score (SMS)
The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
Measured: 1.5 years of therapy
Secondary outcomes (1)
Visual Rating Scale
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startFeb 2003
- Primary completionAug 2008
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Grass Pollen 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludger Klimek, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264459
- Sponsor's protocol ID
- Al0102st
- Status last verified
- Jan 2014
- First submitted
- 12 Dec 2005
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60.
PubMed 17274520Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6.
PubMed 18426146
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.
- ClinicalTrials.gov ID
- NCT00264459
- Acronym / sponsor ID
- Al0102st
- Conditions
- Grass Pollen Allergy
- Keywords
- Sublingual immunotherapy, Rhinoconjunctivitis, Rhinitis, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Dec 2005 (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 trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
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 | Other: ComparatorPlacebo was given the same way as a sublingual preparation. |
| Liquid formulation of an extract of a 6 grass pollen mixture | Experimental | Biological: Grass pollen formulationSublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,
Key exclusion criteria (1 listed)
- Serious chronic diseases, 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 |
|---|---|---|
| Grass pollen formulationAlso: specific immunotherapySolution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. | Biological | Liquid formulation of an extract of a 6 grass pollen mixture |
| ComparatorAlso: Specific ImmunotherapySolution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. | Other | Placebo |
Primary outcome
Symptom and Medication Score (SMS)
Time frame: 1.5 years of therapy
The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
1 secondary outcome
Visual Rating Scale
Time frame: 1.5 years
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 24 Jan 2014.
- Results publication: PubMed 17274520Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60.
- Results publication: PubMed 18426146Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6.
- 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.
Ludger Klimek, M.D. principal investigator
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 Grass pollen formulation and Comparator in people with Grass Pollen Allergy, 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 1 inclusion and 1 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 24 Jan 2014. 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 (SMS) (time frame: 1.5 years of therapy). 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 NCT00264459, which also lists 2 linked publications.
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 24 Jan 2014.