BronchiolitisPhase 2NCT00656916
Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status
A Phase 2 study testing Fluticasone Propionate in people with Bronchiolitis, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Fluticasone Propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >/=18 years of age.
- Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation.
- New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%.
- Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.
- Patient must be willing to comply with all study procedures and capable of signing informed consent.
Who cannot join
- Patients with active pulmonary infection.
- Patients with known hypersensitivity to corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Bronchiolitis
- Being tested
- Fluticasone Propionate
- Keywords
- Post-Transplant Constrictive Bronchiolitis, Bronchiolitis, Fluticasone Propionate, Inhaled Corticosteroids, Lung Condition, PTCB
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
440 micrograms twice daily by oral inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Propionate | Experimental | 440 micrograms twice daily by oral inhalation. Receives: Drug: Fluticasone Propionate |
| Observational Group | No intervention | Comparator group, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara Bashoura, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656916
- Sponsor's protocol ID
- 2007-0390
- Status last verified
- Mar 2012
- First submitted
- 7 Apr 2008
- Last updated
- 23 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00656916
- Acronym / sponsor ID
- 2007-0390
- Conditions
- Bronchiolitis
- Keywords
- Post-Transplant Constrictive Bronchiolitis, Bronchiolitis, Fluticasone Propionate, Inhaled Corticosteroids, Lung Condition, PTCB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 23 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Propionate | Experimental | Drug: Fluticasone Propionate440 micrograms twice daily by oral inhalation. |
| Observational Group | No intervention | –Comparator group, no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >/=18 years of age.
- Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation.
- New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%.
- Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.
- Patient must be willing to comply with all study procedures and capable of signing informed consent.
Key exclusion criteria (2 listed)
- Patients with active pulmonary infection.
- Patients with known hypersensitivity to corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate440 micrograms twice daily by oral inhalation. | Drug | Fluticasone Propionate |
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Bashoura, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Propionate in people with Bronchiolitis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function Non-deterioration Rate (time frame: Baseline and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.