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MOA Study of Ze 339 in Seasonal Allergic Rhinitis (PETRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862225
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Max Zeller Soehne AG

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Placebo Drug: Desloratadin Drug: IG-RD-001 / Ze 339 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Placebo Comparator: 1 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.

Active Comparator: 2 Drug: 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.

Experimental: 3 Drug: 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.




Primary Outcome Measures :
  1. 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 Measures :
  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 [ Time Frame: 0-24h post nasal provocation test ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862225


Locations
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Germany
Dept. of Otorhinolaryngology and Head and Neck Surgery
Dusseldorf, Germany
Sponsors and Collaborators
Max Zeller Soehne AG
Additional Information:
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Responsible Party: Max Zeller Soehne AG
ClinicalTrials.gov Identifier: NCT00862225    
Other Study ID Numbers: PETRA_IG-RD-001 (Ze339)
EudraCT-Number: 2007-006090-89
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012
Keywords provided by Max Zeller Soehne AG:
rhinomanometry
mode of action
grass pollen
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases