Back to results

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

Primary Purpose

Asthma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Humira (adalimumab)

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Changes from Baseline in post-bronchodilator FEV1

Change from Baseline in pre-bronchodilator FEV1

Change from Baseline (pre-bronchodilator) in FEV1

Change from Baseline in percent predicted FEV1

Full Information

NCT ID

NCT00512863

First Posted

August 6, 2007

Last Updated

November 5, 2007

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00512863

Brief Title

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

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Withdrawn

Study Start Date

August 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

272 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Humira (adalimumab)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Time Frame

Week 16

Title

Changes from Baseline in post-bronchodilator FEV1

Time Frame

Time points other thanWeek 16

Title

Change from Baseline in pre-bronchodilator FEV1

Title

Change from Baseline (pre-bronchodilator) in FEV1

Time Frame

30 minutes postbronchodilator

Title

Change from Baseline in percent predicted FEV1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beverly Paperiello

Organizational Affiliation

Abbott

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs