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Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029328
Recruitment Status : Completed
First Posted : January 11, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:
The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Pneumonia Drug: etanercept Phase 1 Phase 2

Detailed Description:
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
Study Start Date : September 2001
Study Completion Date : September 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
  • At least 1 year of age for IPS stratum
  • At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
  • At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
  • Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

Exclusion criteria:

  • Documented evidence of active systemic or pulmonary infection
  • Cardiogenic failure as cause of pulmonary dysfunction
  • Known hypersensitivity to etanercept
  • Currently receiving dialysis
  • Currently receiving inotropic medications except dopamine
  • Pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00029328

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
FDA Office of Orphan Products Development
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Principal Investigator: Kenneth Cooke, M.D. University of Michigan, Ann Arbor, MI
Layout table for additonal information Identifier: NCT00029328    
Other Study ID Numbers: FD-R-2020-01
First Posted: January 11, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: November 2001
Keywords provided by FDA Office of Orphan Products Development:
TNFR-Fc fusion protein
Stem Cell Transplantation
Transplantation, Homologous
Respiratory Function Tests
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Bronchiolitis Obliterans
Acute Lung Injury
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Injury
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors