Evidence map›Paper›PMID 40069946›Full record

Trial reportRespirology (Carlton, Vic.)2025

Objective Effects and Patient Preferences for Ambulatory Oxygen in Fibrotic Interstitial Lung Disease With Isolated Exertional Hypoxaemia: A Placebo-Controlled 6-Minute Walk Test Study.

Giuseppina Ciarleglio, Paolo Cameli, David Bennett, Behar Cekorja, Paola Rottoli, Elisabetta A Renzoni, Piersante Sestini, Elena Bargagli

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respirology (Carlton, Vic.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02668029 (Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis Normoxemic at Rest Who Desaturate on Exercise), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02668029 phase2completednot on this map

Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis Normoxemic at Rest Who Desaturate on Exercise

TypeinterventionalSponsorUniversity of SienaRan2012 to 2013Enrolled32ConditionsPulmonary FibrosisArmsoxygen, medical air
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

8 authors.

Giuseppina CiarleglioDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
Paolo CameliDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
David BennettDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
Behar CekorjaDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
Paola RottoliDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
Elisabetta A RenzoniInterstitial Lung Disease Unit, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' NHS Foundation Trust, and Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK.ORCID 0000-0002-1118-797X
Piersante SestiniDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.ORCID 0000-0002-8195-0811
Elena BargagliDepartment of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe available evidence on the effects of ambulatory oxygen on exercise impairment in patients with fibrotic interstitial lung diseases (F-ILD) is of limited quality.

methodsWe conducted a randomised, double-blind, placebo-controlled crossover trial with 32 normoxaemic F-ILD patients, desaturating to ≤ 88% during a baseline 6-minute walk test (6MWT) on ambient air. After determining the oxygen flow needed to prevent desaturation, patients completed two double-blind 6MWTs with either oxygen or placebo (compressed medical air) at the same personalised flow. Objective measures included oxygen saturation, pulse rate, and distance walked. Patient-reported outcomes, assessed via visual analogue scales, included end-of-test dyspnoea, fatigue, and preferences for walking with oxygen or placebo versus each other and ambient air.

resultsAmbulatory oxygen, compared to placebo, prevented desaturation, reduced tachycardia, increased walking distance by 37 m (95% CI: 10-74, p = 0.008), and lessened dyspnoea and fatigue. The mean preference score for oxygen over placebo was 2.6 (95% CI: 1.9-3.2, p < 0.0005), significantly greater than equivalence. The preference score for placebo over ambient air was -1.5 (-2.4 to 0.64, p = 0.005), significantly lower than equivalence, while the score for oxygen over ambient air was 0.4 (-0.7 to 1.5), not significantly different from equivalence.

conclusionsOur data confirm that ambulatory oxygen provides significant benefits beyond a placebo effect; although in some patients it is associated with a negative perception that may hinder treatment acceptance. This strengthens the evidence supporting current recommendations and suggests that incorporating patient preferences recorded at the time of the 6MWT into clinical discussions can aid shared decision making regarding ambulatory oxygen.

trial registrationClinicalTrials.gov identifier: NCT02668029.

Indexed as

HypoxiaLung Diseases, InterstitialOxygenOxygen Inhalation TherapyPatient PreferenceAgedCross-Over StudiesDouble-Blind MethodDyspneaExercise ToleranceFemaleHumansMaleMiddle AgedWalkingWalk TestOxygen6‐minute walk testambulatory oxygenexercise tolerancefibrotic interstitial lung diseasespatient preferences

Identifiers

PMID40069946
PMCPMC12231771

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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.