Allergic RhinitisPhase 4NCT01059266
PURETHAL Grasses Rush Study
A Phase 4 study testing PURETHAL Grasses, 20.000 AUM/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 11 sites in Germany.
Trial summary
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- PURETHAL Grasses, 20.000 AUM/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesGermany
- Study dates
- Feb 2010to Sep 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years related to grass pollen, eligible for SCIT.
- Confirmation of IgE-mediated allergy by means of:
- Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or
- Specific serum IgE-test (ssIgE >0.7 U/ml) for grass pollen, or
- Positive provocation test for grass pollen.
- Age ≥ 18 years.
- Patients have given a written informed consent
Who cannot join
- Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
- Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
- Active inflammation/infection of the target organs (nose, eyes, lungs).
- Severe atopic dermatitis in need for systemic immunosuppressive medication.
- Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
- Severe kidney disease.
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- Diseases with a contra-indication for the use of adrenaline.
- Treatment with systemic or local beta-blockers or immunosuppressive drugs.
- History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
- Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.
- Participation in a clinical study with a new investigational drug within the last three months.
- Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).
- Alcohol or drug abuse.
- Lack of co-operation or severe psychological disorders.
- Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
- Low compliance or inability to understand instructions/study documents.
- Completed or ongoing treatment with anti-IgE-antibody.
- Patients being in relationship or dependence with the sponsor or investigator.
- Allergy to any of the excipients.
- Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
Bonn, 53127
Practice Blum
Dortmund, 44263
Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
Dresden, 01307
Practice Thieme
Duisburg, 47051
Medaimun GmbH
Frankfurt, 60596
Practice Wrede
Herford, 32052
Dr. med. Jörg Michael Nebel
Koblenz, 56072
Practice Scholz
Mahlow, 15831
St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
Mönchengladbach, 41069
Practice Termeer
Stuttgart, 70499
Zentrum für Rhinologie & Allergologie
Wiesbaden, D - 65183
About this study
Official title: A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).
The primary parameter will be the proportion of patients who experience systemic reactions > grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- PURETHAL Grasses, 20.000 AUM/ml
- Keywords
- immunotherapy, grass pollen, seasonal allergy, dose tolerability
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURETHAL Grasses, 20.000 AUM/mlDrug
subcutaneous injections of increasing doses according to the described regimen
| Study group | Role | What they receive |
|---|---|---|
| conventional regimen of PURETHAL Grasses | Active comparator | Initial treatment:
6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6).
Maintenance treatment:
0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16). Receives: Drug: PURETHAL Grasses, 20.000 AUM/ml |
| rush regimen of PURETHAL Grasses | Experimental | Initial treatment:
3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3)
Maintenance treatment:
3 monthly doses of 0.5 ml (week 7, 11, 15). Receives: Drug: PURETHAL Grasses, 20.000 AUM/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic reactions > grade I or large local reactions related to injection
Measured: 24 hrs after injection
Secondary outcomes (1)
specific serum IgE and IgG concentrations
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Pfaar, MD, Study chair, Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059266
- Sponsor's protocol ID
- P/0035
- Status last verified
- Feb 2012
- First submitted
- 28 Jan 2010
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01059266
- Acronym / sponsor ID
- P/0035
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- immunotherapy, grass pollen, seasonal allergy, dose tolerability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Jan 2010 (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.
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).
The primary parameter will be the proportion of patients who experience systemic reactions > grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional regimen of PURETHAL Grasses | Active comparator | Drug: PURETHAL Grasses, 20.000 AUM/mlInitial treatment: 6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6). Maintenance treatment: 0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16). |
| rush regimen of PURETHAL Grasses | Experimental | Drug: PURETHAL Grasses, 20.000 AUM/mlInitial treatment: 3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3) Maintenance treatment: 3 monthly doses of 0.5 ml (week 7, 11, 15). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years related to grass pollen, eligible for SCIT.
- Confirmation of IgE-mediated allergy by means of:
- Age ≥ 18 years.
- Patients have given a written informed consent
Key exclusion criteria (20 listed)
- Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
- Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
- Active inflammation/infection of the target organs (nose, eyes, lungs).
- Severe atopic dermatitis in need for systemic immunosuppressive medication.
- Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
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 |
|---|---|---|
| PURETHAL Grasses, 20.000 AUM/mlsubcutaneous injections of increasing doses according to the described regimen | Drug | conventional regimen of PURETHAL Grasses, rush regimen of PURETHAL Grasses |
Primary outcome
systemic reactions > grade I or large local reactions related to injection
Time frame: 24 hrs after injection
1 secondary outcome
specific serum IgE and IgG concentrations
Time frame: 16 weeks
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 10 Feb 2012.
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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.
Oliver Pfaar, MD study chair
Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PURETHAL Grasses, 20.000 AUM/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 11 sites 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 7 inclusion and 20 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 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
systemic reactions > grade I or large local reactions related to injection (time frame: 24 hrs after injection). 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 10 Feb 2012.