Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status

This study has been terminated.
(Terminated due to slow accrual.)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: April 7, 2008
Last updated: March 29, 2012
Last verified: March 2012
The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients who continue with standard of care.

Condition Intervention Phase
Drug: Fluticasone Propionate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Early Treatment With Inhaled Corticosteroids Versus Observation for Patients Who Have Decreased Lung Function Status Post Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Lung Function Non-deterioration Rate [ Time Frame: Baseline and three months ] [ Designated as safety issue: No ]
    Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.

Enrollment: 1
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone Propionate
440 micrograms twice daily by oral inhalation.
Drug: Fluticasone Propionate
440 micrograms twice daily by oral inhalation.
No Intervention: Observational Group
Comparator group, no intervention.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients >/=18 years of age.
  2. Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation.
  3. New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%.
  4. Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.
  5. Patient must be willing to comply with all study procedures and capable of signing informed consent.

Exclusion Criteria:

  1. Patients with active pulmonary infection.
  2. Patients with known hypersensitivity to corticosteroids
  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 identifier: NCT00656916

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Lara Bashoura, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00656916     History of Changes
Other Study ID Numbers: 2007-0390 
Study First Received: April 7, 2008
Results First Received: February 7, 2012
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Post-Transplant Constrictive Bronchiolitis
Fluticasone Propionate
Inhaled Corticosteroids
Lung Condition

Additional relevant MeSH terms:
Respiratory Insufficiency
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on May 02, 2016