Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Drug: oxygen; Drug: medical air

Detailed Description

Criteria for inclusion: Patients with a diagnosis of pulmonary fibrosis of any kind, with oxygen saturation >90% in ambient air at rest, showing a desaturation <88% during a preliminary 6 minutes walking test Criteria for exclusion: Inability to give consent, age <18 or >85 years, walking problems from causes different from pulmonary disease

Procedure:

In a preliminary session, the flow of oxygen needed to prevent desaturation during walking is established according to a validated protocol Guyatt et al, Am J Respir Crit Care Med 2001,163:,942-946.) Two 6 minutes walking tests are then performed in a corridor, at least 30' apart, during administration of oxygen or medical air, in random order and double blind, at the same pre-determined flow, administered through a nasal cannula connected to a wall outlet (concealed from sight, being in a side rum at about mid distance in the corridor) through a 10 mt plastic tubing. Oxygen saturation and pulse rate are monitored through a dedicated recording oximeter (Minoxy, Cosmed) , whose display is concealed to both the patient and the operator, with an alarm set for oxygen saturation <70%, to stop the test in case severe desaturation would occur Data are then transferred to computer for analysis only after both test are performed. Walked distance is recorded by the operator unaware of treatment.

At the end of each test, a short questionnaire is administered with 10 cm Visual Analogue Scales (VAS) for dyspnoea, fatigue, and preference compared to performing the test without any treatment. At the end of the second test a further scale is submitted, asking about the preference between the two treatments.

Primary outcomes are the distance walked and the difference in preference of the two treatments compared o no treatment. Secondary outcomes are differences in minimal saturation level and maximal pulse rate during the test and in the report of dyspnea and fatigue at the end of the test, and the reported preference between the two treatments.

Statistical analysis to evaluate the effect of the treatment on walking distance, heart frequency and oxygen saturation is performed using generalized linear model with a gaussian family and identity link and including order of treatment as a fixed effect. Parameters evaluated using VAS are analyzed using Koch adaptation of Wilkoxon rank test (Senn SS. Cross-over Trials in Clinical Research, 2nd Edition. Wiley 2002)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oxygen; oxygen administered through a nasal cannula at a personalized, fixed flow	Drug: oxygen; information already included in arm/group descriptions.; Other Names: ambulatory oxygen
Placebo Comparator: medical air; Medical air administered through a nasal cannula at the same flow	Drug: medical air; Placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in oxygen saturation level	Digitally recorded	Walking test (6 min)
Difference in heart rate	Digitally recorded	Walking test (6 min)
Difference in dyspnea at the end of test	VAS	End of test (6 min)
Difference in fatigue at the end of test	VAS	End of test (6 min)
Preference between the two treatments	VAS	End of both tests (45 min)

Collaborators and Investigators

• Sponsor: University of Siena
• Investigators: Principal Investigator: Piersante Sestini, MD, University of Siena

Publications and helpful links

General Publications

• 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.

Helpful Links

• Senn SS. Cross-over Trials in Clinical Research, 2nd Edition. Wiley 2002

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Oxygen therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: WalkO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO