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New treatment option for Bronchiolitis Obliterans Syndrome (BOS)
Official title Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT03805477
What this study is testing
What is Nintedanib?
Nintedanib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bronchiolitis obliterans syndrome (bos).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation. All study patients with BOS will be treated with the study drug Nintedanib (300 mg/day) as an add-on therapy to their basic immunosuppressive treatment over a 12-months treatment period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Time interval from transplant \</= 5 years at the time of inclusion
- BOS as defined per the National Institute of Health (NIH) criteria:
- FEV1/vital capacity \< 0.7 or the fifth percentile of predicted.
- FEV1 \< 75% of predicted with ≥ 10% decline over less than 2 years.
- Absence of infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs, computed...
You likely can't join if
- Known intolerance to Nintedanib or any of its component
- Pregnancy or nursing
- Serum ALT \> 5 x upper limit of normal (ULN) unless explained entirely by liver GvHD or total bilirubin \> 3x ULN unless explained entirely by liver...
- Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before study inclusion
- Chronic oxygen therapy; non-invasive ventilation
- Inability to give informed consent or to perform repeated pulmonary function tests (PFT)
See the full eligibility criteria
- Time interval from transplant \</= 5 years at the time of inclusion
- BOS as defined per the National Institute of Health (NIH) criteria:
- FEV1/vital capacity \< 0.7 or the fifth percentile of predicted.
- FEV1 \< 75% of predicted with ≥ 10% decline over less than 2 years.
- Absence of infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs, computed tomographic (CT) scans, or microbiologic cultures (sinus aspiration, upper...
- One of the 2 supporting features of BOS: 1. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT, or 2. Evidence of air trapping by PFTs: residual volume \>...
- Diagnosis of BOS within 6 months before enrollment or prior diagnosis of BOS with an absolute decline of the percentage of predicted forced expiratory volume in 1 second (FEV1) by \>/= 10% within the past 12 months...
- Known intolerance to Nintedanib or any of its component
- Pregnancy or nursing
- Serum ALT \> 5 x upper limit of normal (ULN) unless explained entirely by liver GvHD or total bilirubin \> 3x ULN unless explained entirely by liver GvHD
- Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before study inclusion
- Chronic oxygen therapy; non-invasive ventilation
- Inability to give informed consent or to perform repeated pulmonary function tests (PFT)
- Life expectancy \< 1 year at the time of enrolment as suggested by the treating physician
- Hematologic malignancy in hematologic relapse
- Symptomatic angina pectoris
- Therapeutic anticoagulation (primary or secondary prophylactic platelet anti-aggregation allowed)
- Recent abdominal surgery or untreated gastric ulcer
The study team makes the final eligibility decision.
Where it's taking place
- Riyadh, Saudi Arabia
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Riyadh, Saudi Arabia; Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.