Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma

Study Identifier:
C07-002
ClinicalTrials.gov Identifier:
NCT00485576
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: eculizumab
Date
Sep 2007 - Sep 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • :
  • diagnosed with stable, mild, allergic asthma;
  • history of episodic wheeze and shortness of breath;
  • sexually active women of childbearing potential must use contraceptive during the entire duration of study;
  • willing and able to give informed consent;
  • positive methacholine challenge;
  • positive skin prick test to common aeroallergens;
  • positive allergen-induced early and late phase bronchoconstrictor response
  • FEV1 at least 70% of predicted value;
  • PC20 at baseline that is within 1 doubling dose of that measured during screening
  • Exclusion:
  • active bacterial infection;
  • respiratory tract infection or worsening of asthma within 28 days
  • use of inhaled or topical steroids within 28 days or use of systemic corticosteroids within 90 days;
  • use of cromoglycate, nedocromil, leukotriene receptor antagonists and inhibitors of 5-lipoxygenase within 14 days;
  • use of antihistamines, immunosuppressives, or any medications that interact with eculizumab;
  • use of theophylline-containing agents (any type), long-acting beta 2-agonists (salmeterol, formoterol) or long-acting anticholinergics within 14 days;
  • use of NSAIDs prior to spirometry;
  • use of tobacco products currently or within the previous 12 months; or smoking history \> 10 pack-years;
  • lung disease other than mild allergic asthma;
  • patients with LAR who have not been vaccinated against Neisseria meningitidis;
  • hepatitis B or HIV infection;
  • parasitic infection;
  • participation in any other investigational drug trial;
  • pregnant or breast feeding women, or intending to conceive during the course of trial;
  • known hypersensitivity to the treatment drug or any of its excipients;
  • history of illicit drug use or alcohol abuse within previous year;
  • any clinically significant abnormality on screening lab test results;
  • abnormal chest X-ray;
  • chronic use of any other medication for treatment of allergic lung disease other than short-acting beta2-agonists or ipratropium bromide;
  • any medical condition that might interfere with the subject's participation in the study or confound the assessment of the subject;
  • unwilling or inability to comply with the study protocol for any reason.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: eculizumab
Date
Sep 2007 - Sep 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • :
  • diagnosed with stable, mild, allergic asthma;
  • history of episodic wheeze and shortness of breath;
  • sexually active women of childbearing potential must use contraceptive during the entire duration of study;
  • willing and able to give informed consent;
  • positive methacholine challenge;
  • positive skin prick test to common aeroallergens;
  • positive allergen-induced early and late phase bronchoconstrictor response
  • FEV1 at least 70% of predicted value;
  • PC20 at baseline that is within 1 doubling dose of that measured during screening
  • Exclusion:
  • active bacterial infection;
  • respiratory tract infection or worsening of asthma within 28 days
  • use of inhaled or topical steroids within 28 days or use of systemic corticosteroids within 90 days;
  • use of cromoglycate, nedocromil, leukotriene receptor antagonists and inhibitors of 5-lipoxygenase within 14 days;
  • use of antihistamines, immunosuppressives, or any medications that interact with eculizumab;
  • use of theophylline-containing agents (any type), long-acting beta 2-agonists (salmeterol, formoterol) or long-acting anticholinergics within 14 days;
  • use of NSAIDs prior to spirometry;
  • use of tobacco products currently or within the previous 12 months; or smoking history \> 10 pack-years;
  • lung disease other than mild allergic asthma;
  • patients with LAR who have not been vaccinated against Neisseria meningitidis;
  • hepatitis B or HIV infection;
  • parasitic infection;
  • participation in any other investigational drug trial;
  • pregnant or breast feeding women, or intending to conceive during the course of trial;
  • known hypersensitivity to the treatment drug or any of its excipients;
  • history of illicit drug use or alcohol abuse within previous year;
  • any clinically significant abnormality on screening lab test results;
  • abnormal chest X-ray;
  • chronic use of any other medication for treatment of allergic lung disease other than short-acting beta2-agonists or ipratropium bromide;
  • any medical condition that might interfere with the subject's participation in the study or confound the assessment of the subject;
  • unwilling or inability to comply with the study protocol for any reason.

Protocol Summary

This study is to designed to test the role of complement in the late asthmatic response to allergen challenge in mild asthma, as an indicator of the possible role of complement in the broader asthmatic population.

Trial Locations

Location
Status
Location
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Status
N/A
Location
Hospital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Status
N/A