Grass Pollen AllergyPhase 3NCT00263601
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
A Phase 3 study testing Allergovit 6-grasses in people with Grass Pollen Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Grass Pollen Allergy
- What is being tested?
- Allergovit 6-grasses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2001to Aug 2010
- 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
- Positive Skin Prick test to grass pollen
- Positive RAST to grass pollen
- Positive specific provocation test 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 for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Read the detailed description
Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently available in many European and non-European countries. A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.
- Conditions
- Grass Pollen Allergy
- Being tested
- Allergovit 6-grasses, Placebo
- Keywords
- Allergovit, Grass pollen allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovit 6-grassesBiological
Also called Specific immunotherapy with an allergoid preparation.
Subcutaneous injections
PlaceboOther
Also called Comparator
Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Allergovit 6-grasses immunotherapy | Experimental | Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. Receives: Biological: Allergovit 6-grasses |
| Placebo | Placebo comparator | Placebo injections was given the same way: Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and Medication Score
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).
Measured: Assessment after the first and second grass pollen season.
Secondary outcomes (1)
Rhinoconjunctivitis Quality-of-Life Questionnaire
Changes in the scores of Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ by E Juniper) at baseline (outside the grass pollen season), every two weeks during the 3 months grass pollen season (year 1+2).
Measured: First and second grass pollen season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startNov 2001
- Primary completionMay 2004
- Study completionAug 2010
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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annemie Narkus, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263601
- Sponsor's protocol ID
- Al0101av
- Status last verified
- Jun 2014
- First submitted
- 8 Dec 2005
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A; Study Group. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005 Jun;60(6):801-7. doi: 10.1111/j.1398-9995.2005.00790.x.
PubMed 15876311Williams A, Henzgen M, Rajakulasingam K. Additional benefit of a third year of specific grass pollen allergoid immunotherapy in patients with seasonal allergic rhinitis. Eur Ann Allergy Clin Immunol. 2007 Apr;39(4):123-6.
PubMed 17523386
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Placebo Controlled, Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
- ClinicalTrials.gov ID
- NCT00263601
- Acronym / sponsor ID
- Al0101av
- Conditions
- Grass Pollen Allergy
- Keywords
- Allergovit, Grass pollen allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- May 2004 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 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 assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Detailed description
Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently available in many European and non-European countries. A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.
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 |
|---|---|---|
| Allergovit 6-grasses immunotherapy | Experimental | Biological: Allergovit 6-grassesSeven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo injections was given the same way: Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive Skin Prick test to grass pollen
- Positive RAST to grass pollen
- Positive specific provocation test to grass pollen
Key exclusion criteria (2 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 |
|---|---|---|
| Allergovit 6-grassesAlso: Specific immunotherapy with an allergoid preparation.Subcutaneous injections | Biological | Allergovit 6-grasses immunotherapy |
| PlaceboAlso: ComparatorSubcutaneous injections | Other | Placebo |
Primary outcome
Symptom and Medication Score
Time frame: Assessment after the first and second grass pollen season.
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).
1 secondary outcome
Rhinoconjunctivitis Quality-of-Life Questionnaire
Time frame: First and second grass pollen season
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 5 Jun 2014.
- Results publication: PubMed 15876311Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A; Study Group. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005 Jun;60(6):801-7. doi: 10.1111/j.1398-9995.2005.00790.x.
- Results publication: PubMed 17523386Williams A, Henzgen M, Rajakulasingam K. Additional benefit of a third year of specific grass pollen allergoid immunotherapy in patients with seasonal allergic rhinitis. Eur Ann Allergy Clin Immunol. 2007 Apr;39(4):123-6.
- Leader in specific allergy research and therapyLink provided by the sponsor.
Related trials for Grass Pollen Allergy
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GRASS (Grass MATA MPL Real-world Assessment 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.
Annemie Narkus, 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 Allergovit 6-grasses 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 3 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 5 Jun 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 (time frame: Assessment after the first and second grass pollen season.). 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 NCT00263601, 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 5 Jun 2014.