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

A Randomized, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Mild Allergic Asthma.

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: eculizumab

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
  • Quebec
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • Hospital Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge	7 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexion
• Investigators: Study Director: Henk-Andre Kroon, MD, Alexion

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: June 12, 2007
• First Submitted That Met QC Criteria: June 12, 2007
• First Posted (Estimate): June 13, 2007

Study Record Updates

• Last Update Posted (Estimate): January 15, 2009
• Last Update Submitted That Met QC Criteria: January 14, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Complement Inactivating Agents; Eculizumab
• Other Study ID Numbers: C07-002