Clinical trial NCT00512863: A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period
timeFrame: Week 16
measure: Changes from Baseline in post-bronchodilator FEV1
timeFrame: Time points other thanWeek 16
measure: Change from Baseline in pre-bronchodilator FEV1
measure: Change from Baseline (pre-bronchodilator) in FEV1
timeFrame: 30 minutes postbronchodilator
measure: Change from Baseline in percent predicted FEV1
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Beverly Paperiello
role: STUDY_DIRECTOR
References: