Evidence map›Paper›PMID 29234869›Full record

Trial reportLung2018

A Controlled Trial of Inhaled Bronchodilators in Familial Dysautonomia.

Bat-El Bar-Aluma, Ori Efrati, Horacio Kaufmann, Jose-Alberto Palma, Lucy Norcliffe-Kaufmann

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lung, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 37% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Future Trends in Nebulized Therapies for Pulmonary Disease.Journal of personalized medicine · 2020
    Review
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

5 authors at 3 institutions in 2 countries.

Bat-El Bar-AlumaPulmonary Unit and The National Center for Cystic Fibrosis, Edmond and Lily Safra Children's Pediatric Hospital, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel. BatEl.BarAluma@sheba.health.gov.il.
Ori EfratiPulmonary Unit and The National Center for Cystic Fibrosis, Edmond and Lily Safra Children's Pediatric Hospital, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel.
Horacio KaufmannDysautonomia Center, NYU Langone Medical Center, New York University School of Medicine, New York, USA.
Jose-Alberto PalmaDysautonomia Center, NYU Langone Medical Center, New York University School of Medicine, New York, USA.
Lucy Norcliffe-KaufmannDysautonomia Center, NYU Langone Medical Center, New York University School of Medicine, New York, USA.
NYU Langone Health · USEdmond and Lily Safra Children's Hospital · ILSheba Medical Center · IL

Funding

Training CoreU54NS065736 · NINDS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI FREEMAN, ROY · 2009 to 2018
$11.6M
NINDS NIH HHS U54 NS065736
6 · The paper itself

Abstract

backgroundChronic lung disease is a leading cause of premature death in patients with familial dysautonomia (FD). A significant number of patients have obstructive airway disease, yet it is not known whether this is pharmacologically reversible.

methodsWe conducted a double-blind, placebo-controlled, randomized clinical trial comparing the beta 2 agonist albuterol with the muscarinic blocker ipratropium bromide in patients homozygous for the IKBKAP founder mutation. Albuterol, ipratropium bromide, and placebo were administered on 3 separate days via nebulizer in the seated position. Airway responsiveness was evaluated using spirometry and impulse oscillometry 30 min post dose. Cardiovascular effects were evaluated by continuous monitoring of blood pressure, RR intervals, cardiac output, and systemic vascular resistance.

resultsA total of 14 patients completed the trial. Neither active agent had significant detrimental effects on heart rate or rhythm or blood pressure. Albuterol and ipratropium were similar in their bronchodilator effectiveness causing significant improvement in forced expiratory volume in 1-s (FEV1, p = 0.002 and p = 0.030). Impulse oscillometry measures were consistent with a reduction in total airway resistance post nebulization (resistance at 5 Hz p < 0.006).

conclusionAirway obstruction is pharmacologically reversible in a number of patients with FD. In the short term, both albuterol and ipratropium were well tolerated and not associated with major cardiovascular adverse events.

Indexed as

Administration, InhalationAdolescentAdrenergic beta-2 Receptor AgonistsAdultAirway ResistanceAlbuterolBlood PressureBronchodilator AgentsDouble-Blind MethodDysautonomia, FamilialFemaleForced Expiratory VolumeHeart RateHumansIpratropiumLung Diseases, ObstructiveAdrenergic beta-2 Receptor AgonistsAlbuterolBronchodilator AgentsIpratropiumMuscarinic AntagonistsAutonomicBronchodilatorsFamilial dysautonomia/HSAN III

Identifiers

PMID29234869
OpenAlexW2772405591

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.