A Phase 2 interventional study of Fluticasone Propionate in Bronchiolitis, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-23.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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:
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:
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:
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
440 micrograms twice daily by oral inhalation.
Drug: Fluticasone Propionate
Comparator group, no intervention.
440 micrograms twice daily by oral inhalation.
Lung Function Non-deterioration Rate
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.
Time frame: Baseline and three months
Recruitment Period: 03/24/08 through 12/15/10. All participants recruited at UT MD Anderson Cancer Center.
| Milestone | Fluticasone Propionate | Observation |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Propionate | — | 0/1 (0%) | 0/1 (0%) |
| Observation | — | — | — |
| Age Continuous(years) | Fluticasone Propionate | Observation | Total |
|---|---|---|---|
| Median | 46 ± 0 | — | 46 (46 to 46) |
| Gender(participants) | Fluticasone Propionate | Observation | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 0 | — | 0 |
| Region of Enrollment(participants) | Fluticasone Propionate | Observation | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center