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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014