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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

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

NCT ID

NCT00485576

First Posted

June 12, 2007

Last Updated

January 14, 2009

Sponsor

Alexion

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

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

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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