MOA Study of Ze 339 in Seasonal Allergic Rhinitis (PETRA)
January 25, 2012 updated by: Max Zeller Soehne AG
Randomized, Double-blind Prospective Clinical Study to Examine the Mechanism of Action of IG-RD-001 (Ze-339) Compared to Desloratadine and Placebo in Patients With Seasonal Allergic Rhinitis Who Are Sensitized to Grasses
Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses).
The treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dusseldorf, Germany
- Dept. of Otorhinolaryngology and Head and Neck Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Allergic rhinitis since at least 2 years
- Age: = > 18 years
- Consent in accordance with the AMG (=German Drug Law)
- Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is >= 3 mm greater than control; a skin test is positive if the wheal is >= 7 mm greater than control
- Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Exclusion Criteria:
- Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
- Past or current alcohol or medication dependency or abuse
- Bronchial asthma (FEV < 80 %)
- Glaucoma, cataract or ocular herpes simplex
- Clinically relevant deviations from normal laboratory parameters (if known)
- Antihistamines with a long-term effect
- Malignant diseases, including in the patient's case history
- Parasites
- Study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment
- Progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, Aids, HIV infection and other autoimmune diseases
- Other types of rhinitis with different causes, acute or chronic sinusitis
- Pregnancy or lactation
- Serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus
- Patients with rarely occurring hereditary problems galactose-intolerance, Lapp-lactase-deficiency or glucose-galactose-malabsorption
- Pre-existing liver damage
- The use of non-steroidal antirheumatic agents (NSAR)
- Hypersensitivity towards one of the ingredients in the investigational product
- Not adhering to the following periods of abstention before the nasal provocation test: 3 days for DNCG, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. The use of ACE inhibitors or ß-blockers
- Previous organ transplants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
|
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants.
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
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|
Placebo Comparator: 1
|
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants.
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
|
|
Experimental: 3
|
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants.
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Time Frame: 0-24 hours post nasal provocation test
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0-24 hours post nasal provocation test
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical symptom score (rhinorrhoea, nasal congestion, nasal itching and sneezing), assessment by the investigator (nasal secretion, irritation, occurrence of systemic symptoms), mediators in the serum, nasal secretion, nasal curettage and biopsy
Time Frame: 0-24h post nasal provocation test
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0-24h post nasal provocation test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
March 13, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2012
Last Update Submitted That Met QC Criteria
January 25, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PETRA_IG-RD-001 (Ze339)
- EudraCT-Number: 2007-006090-89
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.