MOA Study of Ze 339 in Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862225
• Other study ID #: PETRA_IG-RD-001 (Ze339)
• Secondary ID: EudraCT-Number:
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2009
• Last updated: January 25, 2012
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2012
• Source: Max Zeller Soehne AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a-adrenergic drugs. The use of ACE inhibitors or ß-blockers

• Previous organ transplants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Placebo
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.
• Desloratadin
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.
• IG-RD-001 / Ze 339
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.

Locations

Country	Name	City	State
Germany	Dept. of Otorhinolaryngology and Head and Neck Surgery	Dusseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Max Zeller Soehne AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.		0-24 hours post nasal provocation test	No
Secondary	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		0-24h post nasal provocation test	Yes

External Links

•   Link to publication in PubMed