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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00512863
First received: August 6, 2007
Last updated: November 5, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Humira (adalimumab)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo. [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 272
Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512863

Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00512863     History of Changes
Other Study ID Numbers: M05-757
Study First Received: August 6, 2007
Last Updated: November 5, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014