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

Max Zeller Soehne AG1 site in 1 country18 target enrollmentJanuary 2008

ConditionsSeasonal Allergic Rhinitis

InterventionsPlacebo Desloratadin IG-RD-001 / Ze 339

DrugsPlacebo Desloratadin IG-RD-001 / Ze 339

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Seasonal Allergic Rhinitis
Sponsor: Max Zeller Soehne AG
Enrollment: 18
Locations: 1
Primary Endpoint: The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

December 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Max Zeller Soehne AG

Responsible Party

Sponsor

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

Arms & Interventions

1

Intervention: Placebo

2

Intervention: Desloratadin

3

Intervention: IG-RD-001 / Ze 339

Outcomes

Primary Outcomes

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 Outcomes

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)