Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status

Bronchiolitis Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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 will have a 6-minute walk test. To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be checked throughout the test. To measure oxygen saturation, you will wear a small clip on your finger that will send the oxygen saturation data to a small computer.

• You will also complete St. George's respiratory questionnaire.The questionnaire will have 17 multiple choice or true/false questions about your lung function and overall health. A research nurse will be available to help you with the questionnaire. It will take about 30 minutes to complete.

• You will also complete a NIOX flex test. This measures the amount of nitric oxide in your lungs. While seated, you will exhale and then place the NIOX filter in your mouth. You will then inhale to full lung capacity over 2-3 seconds. Then you will exhale slowly keeping constant flow with the aid of a meter on the computer screen. This is repeated until 3 valid readings are measured and then the test is completed.

Between Weeks 4 and 6, you will have a PFT.

At 3 months, 6 months, and 1 year, the following tests and procedures will be performed:

• You will have a PFT.

• You will complete the St. George's respiratory questionnaire.

• You will have a 6-minute walk test.

• You will have an exhaled nitric oxide (NIOX) Flex test, only at baseline, 3 and 6 months.

Length of Study:

You will be taken off study if the disease gets worse or if intolerable side effects occur. All patients whose condition stayed the same or improved at the end of 1 year will continue study drug and visit schedule.

End-of-Study Visit:

Before you are considered off-study, you will have an end-of-study visit. The following tests and procedures will be performed:

• You will have a PFT.

• You will complete the St. George's respiratory questionnaire.

• You will have a 6-minute walk test.

Follow-Up:

Patients may be contacted by mail or by phone to answer follow-up questions. Follow-up questions and contact frequency will be based on your condition. If you are contacted by phone, the conversation will last about 15 minutes.

This is an investigational study. Fluticasone propionate is FDA approved and commercially available for use in asthma and COPD patients. It's use in PTCB is investigational. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Insufficiency

• NCT number: NCT00656916
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: March 2008
• Completion date: December 2010