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

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. Identifier: NCT00485576
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : January 15, 2009
Information provided by:
Alexion Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: eculizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Mild Allergic Asthma.
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Eculizumab
U.S. FDA Resources

Intervention Details:
    Drug: eculizumab
    eculizumab 600 mg or matching placebo iv infusion.

Primary Outcome Measures :
  1. Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge [ Time Frame: 7 hours ]

Secondary Outcome Measures :
  1. At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells [ Time Frame: 72 hours ]
  2. Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive [ Time Frame: 72 hours ]
  3. Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge [ Time Frame: 7 hours ]
  4. % decrease of FEV1 at 24 hours post-allergen challenge [ Time Frame: 24 hours ]
  5. AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge [ Time Frame: 3 hours ]

Information from the National Library of Medicine

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

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


  • 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.

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 identifier (NCT number): NCT00485576

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Hospital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Alexion Pharmaceuticals
Study Director: Henk-Andre Kroon, MD Alexion Pharmaceuticals

Responsible Party: Alexion Pharmaceuticals Identifier: NCT00485576     History of Changes
Other Study ID Numbers: C07-002
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases