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

NCT00485576 | Completed Phase 2

• 1 other identifier: C07-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

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

  7 hours

Secondary Outcomes (5)

• 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

Interventions

eculizumab DRUG

eculizumab 600 mg or matching placebo iv infusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (2)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Interventions

eculizumab

Study Officials

• Henk-Andre Kroon, MD

  Alexion Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

CA (2)