Clinical Trial: Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

The Study Drug:

Fluticasone propionate is designed to stop the inflammatory action of asthma cells in PTCB.

Screening Tests:

Before you can start treatment on this study, you will have a pulmonary function test (PFT). For this tests, you will be asked to breathe in several different ways while you have a mouthpiece in your mouth to test your lung function.

Study Groups:

If you are found eligible to take part in this study, participants will be assigned to receive fluticasone propionate.

Study Drug Administration:

You will receive fluticasone propionate twice a day by oral inhalation. The study drug will be taken through a metered-dose inhaler. You will be given detailed instructions by the research nurse or clinic nurse at your first study visit.

You will use an Albuterol MDI (rescue inhaler) when needed for shortness of breath. This inhaler is commonly used to treat asthma, chronic obstructive pulmonary disease (COPD), and other respiratory problems. Your clinic nurse will tell you how to use it.

You will fill out a diary to record how often you use the rescue inhaler. You will also record when you take the study drug each week. The diary will be collected at each visit. The diary will take a few minutes to fill out.

Study Visits:

On Day 1, the following tests and procedures will be performed:

• You wi
  Sponsor: M.D. Anderson Cancer Center
  

  Current Primary Outcome: Lung Function Non-deterioration Rate [ Time Frame: Baseline and three months ]

  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.
  
  
  

  Original Primary Outcome: The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of PTCB to patients who continue with standard of care. [ Time Frame: 27 Months ]
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: M.D. Anderson Cancer Center
  

  Dates:
  Date Received: April 7, 2008
  Date Started: March 2008
  Date Completion:
  Last Updated: March 29, 2012
  Last Verified: March 2012