NCT02668029

Brief Summary

Patients with pulmonary fibrosis often desaturate on exercise. There are no data showing whether ambulatory oxygen can be useful to improve exercise capacity in this condition. Ambulatory ambulatory oxygen is often denied to these patients based on studies conducted on patients with chronic obstructive pulmonary disease, a completely different condition for physiopathology, prognosis, and response to therapy. We therefore planned a controlled study to verify the usefulness of ambulatory oxygen in patients with pulmonary fibrosis

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 22, 2016

Last Update Submit

January 28, 2016

Conditions

Pulmonary Fibrosis

Keywords

Oxygen therapy

Outcome Measures

Primary Outcomes (2)

  • distance walked

    recorded by operator

    end of test (6 minutes)

  • Difference in preference of the two treatments compared to no treatment.

    VAS scale

    end of test (6 minutes)

Secondary Outcomes (5)

  • Difference in oxygen saturation level

    Walking test (6 min)

  • Difference in heart rate

    Walking test (6 min)

  • Difference in dyspnea at the end of test

    End of test (6 min)

  • Difference in fatigue at the end of test

    End of test (6 min)

  • Preference between the two treatments

    End of both tests (45 min)

Study Arms (2)

oxygen

EXPERIMENTAL

oxygen administered through a nasal cannula at a personalized, fixed flow

Drug: oxygen

medical air

PLACEBO COMPARATOR

Medical air administered through a nasal cannula at the same flow

Drug: medical air

Interventions

oxygenDRUG

information already included in arm/group descriptions.

Also known as: ambulatory oxygen
oxygen
medical airDRUG

Placebo

Also known as: Placebo
medical air

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary fibrosis of any cause
  • Oxygen saturation =\> 90% at rest in ambient air, and \<88% during walking test

You may not qualify if:

  • Inability to give consent
  • Walking impaired by any condition except pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Guyatt GH, Nonoyama M, Lacchetti C, Goeree R, McKim D, Heels-Ansdell D, Goldstein R. A randomized trial of strategies for assessing eligibility for long-term domiciliary oxygen therapy. Am J Respir Crit Care Med. 2005 Sep 1;172(5):573-80. doi: 10.1164/rccm.200412-1692OC. Epub 2005 May 18.

    PMID: 15901604BACKGROUND

  • Ciarleglio G, Cameli P, Bennett D, Cekorja B, Rottoli P, Renzoni EA, Sestini P, Bargagli E. 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. Respirology. 2025 Jul;30(7):644-651. doi: 10.1111/resp.70020. Epub 2025 Mar 11.

    PMID: 40069946DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Piersante Sestini, MD

    University of Siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 29, 2016

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 29, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share