Back to resultsMOA Study of Ze 339 in Seasonal Allergic Rhinitis (PETRA)
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Placebo
Desloratadin
IG-RD-001 / Ze 339
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring rhinomanometry, mode of action, grass pollen
Eligibility Criteria
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
Sites / Locations
- Dept. of Otorhinolaryngology and Head and Neck Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00862225
Brief Title
MOA Study of Ze 339 in Seasonal Allergic Rhinitis
Acronym
PETRA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Zeller Soehne AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
rhinomanometry, mode of action, grass pollen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Desloratadin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IG-RD-001 / Ze 339
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dept. of Otorhinolaryngology and Head and Neck Surgery
City
Dusseldorf
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21489609
Description
Link to publication in PubMed
Learn more about this trial
MOA Study of Ze 339 in Seasonal Allergic Rhinitis
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