Allergic RhinitisPhase 3NCT01012531
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
A Phase 3 study testing Subcutaneous injections with highly polymerized allergen extract in people with Allergic Rhinitis, run by Roxall Medizin at 1 site in Germany.
Trial summary
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Subcutaneous injections with highly polymerized allergen extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Dec 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
- Positive screening skin prick test (wheal diameter > 3 mm)
- Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- Signed and dated patient´s Informed Consent,
Who cannot join
- Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
- Simultaneous participation in other clinical trials,
- Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- Auto-immune disorders,
- Severe chronic inflammatory diseases,
- Malignancy,
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- Alcohol abuse,
- Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
- Patients being in any relationship or dependency with the sponsor and/or investigator,
- Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
- Conditions
- Allergic Rhinitis
- Being tested
- Subcutaneous injections with highly polymerized allergen extract, Subcutaneous injection with placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous injections with highly polymerized allergen extractBiological
cluster schedule
Subcutaneous injection with placeboBiological
cluster schedule
| Study group | Role | What they receive |
|---|---|---|
| highly polymerized allergen extract | Active comparator | Not described Receives: Biological: Subcutaneous injections with highly polymerized allergen extract |
| Placebo | Placebo comparator | Not described Receives: Biological: Subcutaneous injection with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and medication score
Measured: 1 year
Secondary outcomes (4)
Safety of the treatment during the study period
Measured: 1 year
Documentation of adverse events
Measured: 1 year
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
Measured: 1 year
Global evaluation and Quality of life questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medizin
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012531
- Sponsor's protocol ID
- CLU-2008-001
- Status last verified
- Nov 2009
- First submitted
- 11 Nov 2009
- Last updated
- 14 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization
- ClinicalTrials.gov ID
- NCT01012531
- Acronym / sponsor ID
- CLU-2008-001
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Roxall MedizinIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Nov 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.
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| highly polymerized allergen extract | Active comparator | Biological: Subcutaneous injections with highly polymerized allergen extract |
| Placebo | Placebo comparator | Biological: Subcutaneous injection with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
- Positive screening skin prick test (wheal diameter > 3 mm)
- Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- Signed and dated patient´s Informed Consent,
Key exclusion criteria (10 listed)
- Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
- Simultaneous participation in other clinical trials,
- Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- Auto-immune disorders,
- Severe chronic inflammatory diseases,
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 |
|---|---|---|
| Subcutaneous injections with highly polymerized allergen extractcluster schedule | Biological | highly polymerized allergen extract |
| Subcutaneous injection with placebocluster schedule | Biological | Placebo |
Primary outcome
Symptom and medication score
Time frame: 1 year
4 secondary outcomes
Safety of the treatment during the study period
Time frame: 1 year
Documentation of adverse events
Time frame: 1 year
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
Time frame: 1 year
Global evaluation and Quality of life questionnaire
Time frame: 1 year
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 14 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Subcutaneous injections with highly polymerized allergen extract in people with Allergic Rhinitis, run by Roxall Medizin 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 10 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 Jul 2011. 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: 1 year). 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 14 Jul 2011.