Evidence map›Paper›PMID 28370266›Full record

Trial reportAmerican journal of hematology2017

Inhaled steroids reduce pain and sVCAM levels in individuals with sickle cell disease: A triple-blind, randomized trial.

Jeffrey Glassberg, Caterina Minnitti, Caroline Cromwell, Lawrence Cytryn, Thomas Kraus, Gwen S Skloot, Jason T Connor, Adeeb H Rahman, William J Meurer

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02061202 (Inhaled Mometasone to Promote Reduction in Vasoocclusive Events), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02061202 phase2completednot on this map

Inhaled Mometasone to Promote Reduction in Vasoocclusive Events

TypeinterventionalSponsorJeffrey GlassbergRan2014 to 2017Enrolled54ConditionsSickle Cell DiseaseArmsMometasone Furoate, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Airway Inflammation and Lung Function in Sickle Cell Disease.Pediatric allergy, immunology, and pulmonology · 2019
    Article
  13. Review
  14. Review
  15. New insights into the pathophysiology and development of novel therapies for sickle cell disease.Hematology. American Society of Hematology. Education Program · 2018
    Review
  16. Measuring success: utility of biomarkers in sickle cell disease clinical trials and care.Hematology. American Society of Hematology. Education Program · 2018
    Review
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Jeffrey GlassbergDepartment of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York.
Caterina MinnittiDepartment of Oncology, Montefiore Medical Center, Bronx, New York.
Caroline CromwellDepartment of Hematology and Oncology, Icahn School of Medicine at Mount Sinai Beth Israel, New York.
Lawrence CytrynDepartment of Hematology and Oncology, Icahn School of Medicine at Mount Sinai Beth Israel, New York.
Thomas KrausCenter for Therapeutic Antibody Development, Icahn School of Medicine at Mount Sinai, New York.
Gwen S SklootDepartment of Pulmonary, Critical Care and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York.
Jason T ConnorBerry Consultants, Austin, Texas.
Adeeb H RahmanDepartment of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York.
William J MeurerDepartments of Emergency Medicine and Neurology, University of Michigan, Ann Arbor, Michigan.
Icahn School of Medicine at Mount Sinai · USBerry & Associates (United States) · USMichigan Medicine · USMontefiore Medical Center · USMount Sinai Beth Israel · US

Funding

Inhaled Mometasone to Promote Reduction in Vaso-occlusive Events (IMPROVE)K23HL119351 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI GLASSBERG, JEFFREY AVINS · 2013 to 2017
$857k
NHLBI NIH HHS K23 HL119351
6 · The paper itself

Abstract

Clinical and preclinical data demonstrate that altered pulmonary physiology (including increased inflammation, increased blood flow, airway resistance, and hyper-reactivity) is an intrinsic component of Sickle Cell Disease (SCD) and may contribute to excess SCD morbidity and mortality. Inhaled corticosteroids (ICS), a safe and effective therapy for pulmonary inflammation in asthma, may ameliorate the altered pulmonary physiologic milieu in SCD. With this single-center, longitudinal, randomized, triple-blind, placebo controlled trial we studied the efficacy and feasibility of ICS in 54 nonasthmatic individuals with SCD. Participants received once daily mometasone furoate 220 mcg dry powder inhalation or placebo for 16 weeks. The primary outcome was feasibility (the number who complete the trial divided by the total number enrolled) with prespecified efficacy outcomes including daily pain score over time (patient reported) and change in soluble vascular cell adhesion molecule (sVCAM) levels between entry and 8-weeks. For the primary outcome of feasibility, the result was 96% (52 of 54, 95% CI 87%-99%) for the intent-to-treat analysis and 83% (45 of 54, 95% CI 71%-91%) for the per-protocol analysis. The adjusted treatment effect of mometasone was a reduction in daily pain score of 1.42 points (95%CI 0.61-2.21, P = 0.001). Mometasone was associated with a reduction in sVCAM levels of 526.94 ng/mL more than placebo (95% CI 50.66-1003.23, P = 0.03). These results support further study of ICS in SCD including multicenter trials and longer durations of treatment. www.clinicaltrials.gov (NCT02061202).

Indexed as

Acute Chest SyndromeAdministration, InhalationAdultAnemia, Sickle CellAntisickling AgentsBiomarkersComorbidityCytokinesFemaleHumansMaleMedication AdherenceMiddle AgedOdds RatioPainPain MeasurementAntisickling AgentsBiomarkersCytokinesSteroidsVascular Cell Adhesion Molecule-1

Identifiers

PMID28370266
PMCPMC5484635
OpenAlexW2598384706

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.