MOA Study of Ze 339 in Seasonal Allergic Rhinitis

NCT00862225 | Completed Phase 2

• 2 other identifiers: PETRA_IG-RD-001 (Ze339)EudraCT-Number: 2007-006090-89
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

rhinomanometry; mode of action; grass pollen

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

ACTIVE COMPARATOR

Drug: Desloratadin

3

EXPERIMENTAL

Drug: IG-RD-001 / Ze 339

Interventions

Placebo DRUG

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.

1

Desloratadin DRUG

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.

2

IG-RD-001 / Ze 339 DRUG

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.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Zeller Soehne AG: lead

Study Sites (1)

Dept. of Otorhinolaryngology and Head and Neck Surgery

Düsseldorf, Germany

Location

Related Links

• Link to publication in PubMed

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Ze 339

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

DE (1)