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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00512863
• Other study ID #: M05-757
• Status: Withdrawn
• Phase: Phase 2
• First received: August 6, 2007
• Last updated: November 5, 2007
• Start date: August 2007

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 272
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Humira (adalimumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.		Week 16
Secondary	Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period		Week 16
Secondary	Changes from Baseline in post-bronchodilator FEV1		Time points other thanWeek 16
Secondary	Change from Baseline in pre-bronchodilator FEV1
Secondary	Change from Baseline (pre-bronchodilator) in FEV1		30 minutes postbronchodilator
Secondary	Change from Baseline in percent predicted FEV1