Effects of Imatinib in Subjects With Seasonal Allergic Rhinitis and Who Are Sensitive to Timothy Grass Pollen

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426179
First received: January 23, 2007
Last updated: November 16, 2007
Last verified: November 2007
  Purpose

This study will assess the effects of Imatinib on allergic inflammation following repeated nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy grass pollen.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Imatinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Effects of Imatinib on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen - an Exploratory Study of c-Kit Inhibition in Allergic Respiratory Diseases

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effect of Imatinib on the reduction of mast cell degranulation (measured by β-tryptase and PGD2) in response to allergen challenge

Secondary Outcome Measures:
  • Additional markers of inflammation following nasal allergen challenge (NAC):
  • Enumeration of eosinophils in nasal lavage following NAC
  • Total nasal symptom score (TNSS) following NAC
  • Soluble mediators collected from adsorption onto nasal filter papers following NAC, with a focus on Th2-associated cytokines

Estimated Enrollment: 30
Study Start Date: December 2006
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy male non-smoking subjects aged 18-55 years, with a history of seasonal allergic rhinitis consistent with Timothy grass pollen allergy. They must show: a positive skin prick test to Timothy grass pollen (wheal difference Timothy grass pollen - negative control ≥ 3 mm) at or within the 12 months preceding the screening visit and demonstrate symptomatic worsening (TNSS ≥4) within one hour after nasal allergen challenge
  • Be otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.
  • Subjects and their partners must agree to use effective contraceptive measures from screening until the end of study visit.

Exclusion Criteria:

  • Respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function.
  • Structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, recent nasal surgery or recent (within 8 weeks prior to baseline visit) or recent (four weeks) or ongoing upper or lower respiratory tract infection.
  • Use of any medication that would affect the response to the allergen challenge (e.g. corticosteroids, decongestants, anti-histamines, medications with anti-inflammatory effects) or any other nasally applied medication within 14 days prior to allergen challenge (30 days for systemic anti-inflammatory therapy including oral corticosteroids), or known to influence Imatinib bioavailability or clearance
  • History or laboratory evidence of acute or chronic renal insufficiency or abnormal liver function.
  • Subjects may voluntarily withdraw from or be withdrawn from the study at the discretion of the investigator or the sponsor at any time. Subjects may be withdrawn from the study prematurely for one of the following reasons:
  • Subject withdrew consent
  • Upper respiratory tract infection
  • Presence of allergic rhinitis symptoms in the screening period or prior to pre-wash on Day 1
  • A past medical history of inherited heart disease, valve defect, cardiomyopathy, rheumatic fever, arrhythmias, cardiac interventions or clinically significant ECG abnormalities.
  • Adverse events and non-tolerable symptoms resulting from allergen challenge
  • Administration of a concomitant medication (other than those randomized to receive Fluticasone propionate) that would impact on the study results (e.g. corticosteroids), including any subjects requiring asthma therapy (inhaled or systemic).

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426179

Locations
United Kingdom
Novartis Investigative site
Horsham, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426179     History of Changes
Other Study ID Numbers: CSTI571E2204
Study First Received: January 23, 2007
Last Updated: November 16, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Imatinib, allergic inflammation, out of allergy season, repeated nasal allergen, seasonal allergic rhinitis, sensitive, Timothy grass pollen, c-kit inhibition

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014