PURETHAL Grasses Rush Study
This study has been completed.
Sponsor:
HAL Allergy
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT01059266
First received: January 28, 2010
Last updated: February 9, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis Allergic Rhinoconjunctivitis |
Drug: PURETHAL Grasses, 20.000 AUM/ml |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by HAL Allergy:
Primary Outcome Measures:
- systemic reactions > grade I or large local reactions related to injection [ Time Frame: 24 hrs after injection ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- specific serum IgE and IgG concentrations [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | February 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: conventional regimen of PURETHAL Grasses
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). |
Drug: PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen
|
|
Experimental: rush regimen of PURETHAL Grasses
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). |
Drug: PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- 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
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059266
Locations
| Germany | |
| Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie | |
| Bonn, Germany, 53127 | |
| Practice Blum | |
| Dortmund, Germany, 44263 | |
| Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO | |
| Dresden, Germany, 01307 | |
| Practice Thieme | |
| Duisburg, Germany, 47051 | |
| Medaimun GmbH | |
| Frankfurt, Germany, 60596 | |
| Practice Wrede | |
| Herford, Germany, 32052 | |
| Dr. med. Jörg Michael Nebel | |
| Koblenz, Germany, 56072 | |
| Practice Scholz | |
| Mahlow, Germany, 15831 | |
| St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie | |
| Mönchengladbach, Germany, 41069 | |
| Practice Termeer | |
| Stuttgart, Germany, 70499 | |
| Zentrum für Rhinologie & Allergologie | |
| Wiesbaden, Germany, D - 65183 | |
Sponsors and Collaborators
HAL Allergy
Investigators
| Study Chair: | Oliver Pfaar, MD | Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden |
More Information
No publications provided
| Responsible Party: | HAL Allergy |
| ClinicalTrials.gov Identifier: | NCT01059266 History of Changes |
| Other Study ID Numbers: | P/0035 |
| Study First Received: | January 28, 2010 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by HAL Allergy:
|
immunotherapy grass pollen seasonal allergy dose tolerability |
Additional relevant MeSH terms:
|
Rhinitis Conjunctivitis, Allergic Conjunctivitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013