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Bronchiolitis Obliterans Syndrome (BOS)Phase 2NINBOST2018NCT03805477

Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation

A Phase 2 study testing Nintedanib in people with Bronchiolitis Obliterans Syndrome (BOS) and Bronchiolitis Obliterans (BO), run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nintedanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesin 2 countries
Study dates
20 Mar 2019to 29 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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 respiratory tract viral screen, sputum culture, and broncho-alveolar lavage).
  • 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 > 120% of predicted or residual volume/total lung capacity elevated outside the 90% confidence interval and prior or current diagnosis of cGvHD per NIH criteria or histologically proven BO
  • 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 before inclusion

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Switzerland2 sites

  • Clinic of Hematology, University Hospital Basel

    Basel, 4031

  • Clinic of Respiratory Medicine, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Centre

    Riyadh, 11471

Other trials in Saudi Arabia

About this study

Official title: Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial

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.

Read the detailed description

Allogeneic hematopoietic stem cell transplantation (HCT) is an established treatment option for several malignant and non-malignant disorders. An important limitation of long-term survival after HCT is chronic graft-versus-host disease (cGvHD). The manifestation of cGvHD in the lungs, bronchiolitis obliterans (BO - if proven by lung biopsy) or bronchiolitis obliterans syndrome (BOS - clinical diagnosis), has a reported incidence between 5 and 20%. Despite different treatment approaches, prognosis of BO remains poor, with an overall 3-year mortality of up to 65%. Nintedanib is an orally available indolinone derivate that competitively binds to the vascular endothelial growth factor (VEGF) receptors, fibroblast growth factor (FGF) receptors, and platelet derived growth factor (PDGF) receptors. The anti-fibrotic activities of Nintedanib may impact the progressive course of fibrotic lung diseases like BO. This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome following allogeneic hematopoietic cell transplantation.

Being tested
Nintedanib
Keywords
allogeneic hematopoietic cell transplantation., chronic graft-versus-host disease (cGvHD), Nintedanib, fibrotic lung disease
Medical subject headings
Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NintedanibDrug

    Nintedanib 150 mg Kps bid (oral); in order to manage adverse events, the dose of Nintedanib may be reduced from 150 mg twice daily to 100 mg twice daily

Study groups in NCT03805477
Study groupRoleWhat they receive
NintedanibExperimentalNintedanib 150 mg Kps bid (oral)
Receives: Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse event rate leading to interruption/ discontinuation of study treatment

    adverse events of the following severity according to Common terminology criteria for adverse events(CTCAE): Diarrhoea ≥ grade 3; Nausea ≥ grade 3; Vomiting ≥ grade 3; Abdominal pain ≥ grade 3; Elevation of liver enzymes (AST, ALT) ≥ grade 2; Elevation of total bilirubin ≥ 2

    Measured: from screening to month 12 after screening

Secondary outcomes (14)

  1. change of the percent of predicted forced expiratory volume in 1 second (FEV1)

    absolute change of the percent of predicted FEV1 by ≥10% from FEV1 before enrolment (eg, 50% to 40% predicted FEV1), confirmed by 2 pulmonary function tests (PFT) performed at least two weeks apart and after exclusion of infections and extra pulmonary causes

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  2. change in forced vital capacity (FVC)

    volume of air that can forcibly be blown out after full inspiration, (measured in Liters)

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  3. change in total lung capacity (TLC)

    the volume in the lungs at maximal Inflation (measured in liters)

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  4. Change in diffusion capacity of the lung for carbon monoxide (DLCO)

    extent to which oxygen passes from the air sacs of the lungs into the blood (measured in "ml/min/kPa)

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  5. Change in exhaled nitric oxide (eNO)

    Change in exhaled nitric oxide (eNO) (measured in parts per Billion)

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  6. Nitrogen (N2)-washout

    The following describes a single-breath nitrogen test: A subject takes a breath of 100% oxygen and exhales through a one-way valve measuring nitrogen content and volume. A plot of the nitrogen concentration (as a % of total gas) vs. expired volume is obtained by increasing the nitrogen concentration from zero to the percentage of nitrogen in the alveoli. The nitrogen concentration is initially zero because the subject is exhaling the dead space oxygen they just breathed in (does not participate in alveolar exchange), and climbs as alveolar air mixes with the dead space air. The dead space can be determined from this curve by drawing a vertical line down the curve such that the areas below the curve (left of the line) and above the curve (right of the line) are equal

    Measured: Pulmonary function tests will be performed at screening, after 1, 2, 3, 6, 9, 12 and after 13 months

  7. changes in in 6 minutes walking distance (6-MWD)

    standardized 6-minute walk test will be performed breathing room air and performed according to the guidelines of the American Thoracic Society. Significant drop of transcutaneous measured arterial oxygen Saturation (SaO2) is defined as a ΔSaO2 ≥ 4% or SaO2 < 90%. A significant change in walking distance will be Δ distance = 40 metre.

    Measured: 6-MWD will be performed at screening, after 6, after 12 months

  8. cumulative steroid doses

    steroid doses per month (in mg)

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  9. occurrence of GvHD in other organs

    occurrence of GvHD in other organs

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  10. disease-free survival of underlying hematologic disease

    disease-free survival of underlying hematologic disease

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  11. changes in St. George's Respiratory Questionnaire (SGRQ)

    The SGRQ is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD); 3 component scores are calculated: symptoms; activity; impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100.

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  12. changes in NIH GvHD grading score

    NIH symptom-based lung score (score 0: no symptoms, score 1: shortness of breath with stairs, score 2: shortness of breath on flat ground, score 3: shortness of breath at rest or requiring oxygen)

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  13. changes in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire

    specific HSCT-patients validated self-report questionnaire using a 5 point Likert scale and covering 4 specific domains that include physical, social and family, emotional and functional well-being. Scoring produces a range from 0-148, the higher the score, the better the Quality of Life (QOL).

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

  14. overall survival

    overall survival

    Measured: assessed at screening, after 1, 2, 3, 6, 9, 12, and after 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start20 Mar 2019
  3. Primary completion29 Jul 2026
  4. Study completion29 Jul 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805477
Sponsor's protocol ID
2018-00837; me17Hostettler
Other IDs
2018
Acronym
NINBOST2018
Status last verified
Oct 2026
First submitted
8 Jan 2019
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nintedanib in people with Bronchiolitis Obliterans Syndrome (BOS) and Bronchiolitis Obliterans (BO), run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.

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 7 inclusion and 11 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland, Saudi Arabia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

adverse event rate leading to interruption/ discontinuation of study treatment (time frame: from screening to month 12 after screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805477.

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 27 Oct 2026.

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