Allergic AsthmaPhase 2NCT00485576
Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma
A Phase 2 study testing eculizumab in people with Allergic Asthma, run by Alexion Pharmaceuticals, Inc. at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- eculizumab
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
Hospital Laval
Ste-Foy, Quebec, G1V 4G5
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Mild Allergic Asthma.
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
- Being tested
- eculizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eculizumabDrug
eculizumab 600 mg or matching placebo iv infusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge
Measured: 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
Measured: 72 hours
Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive
Measured: 72 hours
Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge
Measured: 7 hours
% decrease of FEV1 at 24 hours post-allergen challenge
Measured: 24 hours
AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henk-Andre Kroon, MD, Study director, Alexion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485576
- Sponsor's protocol ID
- C07-002
- Status last verified
- Jan 2009
- First submitted
- 12 Jun 2007
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Mild Allergic Asthma.
- ClinicalTrials.gov ID
- NCT00485576
- Acronym / sponsor ID
- C07-002
- Conditions
- Allergic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eculizumabeculizumab 600 mg or matching placebo iv infusion. | Drug | – |
Primary outcome
Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge
Time frame: 7 hours
5 secondary outcomes
At 24 hours post-allergen challenge; treatment comparison of allergen-induced changes from baseline in sputum eosinophils and metachromatic cells
Time frame: 72 hours
Allergen-induced airway responsiveness 24 hours post-allergen challenge as primary interest; 72 hour assessment timepoint will be supportive
Time frame: 72 hours
Maximum % decrease in FEV1 from 3 to 7 hours post-allergen challenge
Time frame: 7 hours
% decrease of FEV1 at 24 hours post-allergen challenge
Time frame: 24 hours
AUC and maximum % fall of FEV1 from 0-3 hours post-allergen challenge
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk-Andre Kroon, MD study director
Alexion Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eculizumab in people with Allergic Asthma, run by Alexion Pharmaceuticals, Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergen-induced late asthmatic response as measured by the AUC of FEV1 from 3 to 7 hours post-allergen challenge (time frame: 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2009.