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

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
eculizumab
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergic Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster University
  • Hospital Laval

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2007
Last Updated
January 14, 2009
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT00485576
Brief Title
Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alexion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
eculizumab
Intervention Description
eculizumab 600 mg or matching placebo iv infusion.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells
Time Frame
72 hours
Title
Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive
Time Frame
72 hours
Title
Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge
Time Frame
7 hours
Title
% decrease of FEV1 at 24 hours post-allergen challenge
Time Frame
24 hours
Title
AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk-Andre Kroon, MD
Organizational Affiliation
Alexion
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hospital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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

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