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

NCT ID: NCT00485576

Last Updated: 2009-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-11-30

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.

Conditions

Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

eculizumab

eculizumab 600 mg or matching placebo iv infusion.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Alexion Pharmaceuticals

Principal Investigators

Henk-Andre Kroon, MD

Role: STUDY_DIRECTOR

Alexion Pharmaceuticals, Inc.

Locations

McMaster University

Hamilton, Ontario, Canada

Hospital Laval

Ste-Foy, Quebec, Canada

Countries

Canada

Other Identifiers

C07-002

Identifier Type: -

Identifier Source: org_study_id