A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma

NCT00512863 | Withdrawn Phase 2

• 1 other identifier: M05-757
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.

  Week 16

Secondary Outcomes (5)

• Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period

  Week 16

• Changes from Baseline in post-bronchodilator FEV1

  Time points other thanWeek 16

• Change from Baseline in pre-bronchodilator FEV1

• Change from Baseline (pre-bronchodilator) in FEV1

  30 minutes postbronchodilator

• Change from Baseline in percent predicted FEV1

Interventions

Humira (adalimumab) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Asthma

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Beverly Paperiello

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Last Updated: November 6, 2007

Record last verified: 2007-11