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

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485576
• Other study ID #: C07-002
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2007
• Last updated: January 14, 2009
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• eculizumab
eculizumab 600 mg or matching placebo iv infusion.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Hospital Laval	Ste-Foy	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge		7 hours	No
Secondary	At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells		72 hours	No
Secondary	Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive		72 hours	No
Secondary	Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge		7 hours	No
Secondary	% decrease of FEV1 at 24 hours post-allergen challenge		24 hours	No
Secondary	AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge		3 hours	No