Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2016
Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation.
Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01307462 (Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant), which is not on this map. Cited by 96 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant
Who cites it
96 citing papers in PubMed, 6 syntheses or guidelines pooled it, 208 citations in OpenAlex.
- Taiwan consensus on pulmonary chronic graft-versus-host disease: A joint statement from the Taiwan Society of Blood and Marrow Transplantation (TBMT) and Taiwan Society of Pulmonary and Critical Care Medicine (TSPCCM).British journal of haematology · 2025Guideline
- Pulmonary function testing in pediatric allogeneic stem cell transplant recipients to monitor for Bronchiolitis obliterans syndrome: a systematic review.BMC pediatrics · 2025Pooled it
- Cell Therapy Transplant Canada (CTTC) Consensus-Based Guideline 2024 for Management and Treatment of Chronic Graft-Versus-Host Disease and Future Directions for Development.Current oncology (Toronto, Ont.) · 2024Guideline
- Effect of azithromycin on bronchiolitis obliterans syndrome in posttransplant recipients: A systematic review and meta-analysis.Medicine · 2022Pooled it
- Diagnosis and treatment of bronchiolitis obliterans syndrome accessible universally.Bone marrow transplantation · 2019Pooled it
- Azithromycin for the Treatment of Obliterative Bronchiolitis after Hematopoietic Stem Cell Transplantation: A Systematic Review and Meta-Analysis.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016Pooled it
- A phase 2 multicenter trial of ruxolitinib to treat bronchiolitis obliterans syndrome after allogeneic HCT.Blood advances · 2025Trial
- Trial
- The safety and tolerability of pirfenidone for bronchiolitis obliterans syndrome after hematopoietic cell transplant (STOP-BOS) trial.Bone marrow transplantation · 2022Trial
- Prospective Phase II Trial of Montelukast to Treat Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation and Investigation into Bronchiolitis Obliterans Syndrome Pathogenesis.Transplantation and cellular therapy · 2022Trial
- The efficacy of mesenchymal stem cells in bronchiolitis obliterans syndrome after allogeneic HSCT: A multicenter prospective cohort study.EBioMedicine · 2019Trial
- Bortezomib is safe in and stabilizes pulmonary function in patients with allo-HSCT-associated pulmonary CGVHD.Bone marrow transplantation · 2018Trial
- Montelukast for bronchiolitis obliterans syndrome after lung transplantation: A randomized controlled trial.PloS one · 2018Trial
- Trial
- [Chinese expert consensus on the diagnosis and treatment of pulmonary chronic graft-versus-host disease (2026)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- Prophylactic Donor Lymphocyte Infusions in Pediatric Patients With High-Risk Hematological Malignancies.European journal of haematology · 2026Article
- Diagnosis and Management of Small Airways Disease.CHEST pulmonary · 2026Review
- Risk factors for alloimmune lung syndromes after allogeneic hematopoietic cell transplantation in children.Bone marrow transplantation · 2026Article
- Therapeutic interventions and pulmonary function in pediatric patients with post-infectious bronchiolitis obliterans.World journal of clinical pediatrics · 2026Review
- Late onset non-infectious pulmonary complications and pre-transplant pulmonary function as prognostic factors in allo-HCT using post-transplant cyclophosphamide.Frontiers in immunology · 2026Article
36 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
19 authors at 12 institutions in 1 country.
Funding
Abstract
Bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT) is associated with high mortality. We hypothesized that inhaled fluticasone, azithromycin, and montelukast (FAM) with a brief steroid pulse could avert progression of new-onset BOS. We tested this in a phase II, single-arm, open-label, multicenter study (NCT01307462). Thirty-six patients were enrolled within 6 months of BOS diagnosis. The primary endpoint was treatment failure, defined as 10% or greater forced expiratory volume in 1 second decline at 3 months. At 3 months, 6% (2 of 36, 95% confidence interval, 1% to 19%) had treatment failure (versus 40% in historical controls, P < .001). FAM was well tolerated. Steroid dose was reduced by 50% or more at 3 months in 48% of patients who could be evaluated (n = 27). Patient-reported outcomes at 3 months were statistically significantly improved for Short-Form 36 social functioning score and mental component score, Functional Assessment of Cancer Therapies emotional well-being, and Lee symptom scores in lung, skin, mouth, and the overall summary score compared to enrollment (n = 24). At 6 months, 36% had treatment failure (95% confidence interval, 21% to 54%, n = 13 of 36, with 6 documented failures, 7 missing pulmonary function tests). Overall survival was 97% (95% confidence interval, 84% to 100%) at 6 months. These data suggest that FAM was well tolerated and that treatment with FAM and steroid pulse may halt pulmonary decline in new-onset BOS in the majority of patients and permit reductions in systemic steroid exposure, which collectively may improve quality of life. However, additional treatments are needed for progressive BOS despite FAM.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.