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

This study has been completed.
Sponsor:
Information provided by:
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00485576
First received: June 12, 2007
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Allergic Asthma
Drug: eculizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
  • % decrease of FEV1 at 24 hours post-allergen challenge [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: eculizumab
    eculizumab 600 mg or matching placebo iv infusion.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485576

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

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00485576     History of Changes
Other Study ID Numbers: C07-002
Study First Received: June 12, 2007
Last Updated: January 14, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 25, 2014