AsthmaPhase 2NCT00512863
A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
A Phase 2 study testing Humira (adalimumab) in people with Asthma, run by Abbott.
Trial summary
To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Humira (adalimumab)
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to not given
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
- Actual or documented history of reversible airway obstruction
- Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
- History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
- Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
- Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
Who cannot join
- Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [COPD], interstitial lung disease, pulmonary fibrosis) other than asthma
- Current treatment for corticosteroid-resistant asthma (e.g., methotrexate [MTX], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [IGIV], mycophenolate mofetil)
- History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
- History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
- Females who are pregnant or will not discontinue breast-feeding.
- Subject with a history of clinically significant drug or alcohol abuse in the last year
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- Subjects with a poorly controlled medical condition.
- Abnormal, clinically significant screening laboratory and other analyses (including ECG).
- Subjects with any prior exposure to Tysabri® (natalizumab)
- Prior treatment with any TNF antagonist, including adalimumab
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.
- Conditions
- Asthma
- Being tested
- Humira (adalimumab)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humira (adalimumab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
Measured: Week 16
Secondary outcomes (5)
Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period
Measured: Week 16
Changes from Baseline in post-bronchodilator FEV1
Measured: Time points other thanWeek 16
Change from Baseline in pre-bronchodilator FEV1
Change from Baseline (pre-bronchodilator) in FEV1
Measured: 30 minutes postbronchodilator
Change from Baseline in percent predicted FEV1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beverly Paperiello, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512863
- Sponsor's protocol ID
- M05-757
- Status last verified
- Nov 2007
- First submitted
- 6 Aug 2007
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
- ClinicalTrials.gov ID
- NCT00512863
- Acronym / sponsor ID
- M05-757
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- First posted
- 8 Aug 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.
To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
- Actual or documented history of reversible airway obstruction
- Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
- History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
- Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
Key exclusion criteria (10 listed)
- Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [COPD], interstitial lung disease, pulmonary fibrosis) other than asthma
- Current treatment for corticosteroid-resistant asthma (e.g., methotrexate [MTX], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [IGIV], mycophenolate mofetil)
- History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
- History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
- Females who are pregnant or will not discontinue breast-feeding.
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 |
|---|---|---|
| Humira (adalimumab) | Drug | – |
Primary outcome
The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
Time frame: Week 16
5 secondary outcomes
Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period
Time frame: Week 16
Changes from Baseline in post-bronchodilator FEV1
Time frame: Time points other thanWeek 16
Change from Baseline in pre-bronchodilator FEV1
Change from Baseline (pre-bronchodilator) in FEV1
Time frame: 30 minutes postbronchodilator
Change from Baseline in percent predicted FEV1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
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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.
Beverly Paperiello study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Humira (adalimumab) in people with Asthma, run by Abbott.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo. (time frame: Week 16). 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 6 Nov 2007.