Short-term Effects of Supplemental Oxygen in Patients With IPF (IPFO2)

December 3, 2018 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis

Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Given, that walking ability is the most important activity of daily life, the aim of our study is to investigate the effects of supplemental oxygen on endurance walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a double-blinded fashion and random order.

Since there are only limited pharmacological treatment options for IPF patients, this study may help to provide novel information about the short-term effects of supplemental oxygen. Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to facilitate patients´ participation in activities of daily life and not at least to improve patients´ quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale:

Exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis and predicts poorer outcomes. However, prospective studies with larger sample sizes and those investigating the effect of oxygen on endurance time, oxygen saturation and breathing frequency during walking are lacking. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of supplemental oxygen during walking in IPF patients.

The endurance shuttle walk test (ESWT) is a well validated test with high reliability and validity for measuring endurance walking capacity in patients with chronic obstructive pulmonary disease (COPD). The advantage of this test in contrast to the 6-minute walk test is that the ESWT is performed at 85% of the individual maximum that is close to the intensity of typical daily activities. Additionally, by using the ESWT it is possible to determine the maximum duration of exercise and to compare values at isotime (= time point when the shortest of the 3 ESWTs ends), whereas values at the end of different six-minute walk tests (6MWTs) are not comparable in case of different distances.

Aim:

To investigate the short-term effects of supplemental oxygen on endurance capacity during walking (ESWT) in patients with idiopathic pulmonary fibrosis.

Design:

This study is a randomized, controlled, double-blinded cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum walking capacity, patients will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on 2l/min oxygen, one on 4l/min oxygen and one on medical air (=compressed room air), whereas the patients as well as the investigator will be blinded to the gas mixture provided. All 3 conditions will be provided via nasal cannula. The time between the two ESWTs will be 24 hours in order to give enough time for regeneration. Endurance Walking capacity as measured by the ESWT will be used as the primary outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau Am Königssee, Germany, 83471
        • Schoen Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • patients with idiopathic pulmonary fibrosis and hypoxemia at rest or during exercise (PaO2 <55 mmHg or SpO2 <88%)
  • Written informed consent

Exclusion criteria:

  • Forced vital capacity < 50% pred.
  • Clinical signs of any cardial comorbidity
  • Not able to walk
  • Oxygen flow needed during exercise > 4l/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ESWT order 1

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. medical air (MA)
  2. Oxygen (2 Liter/min)
  3. Oxygen (4 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 2

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. medical air (MA)
  2. Oxygen (4 Liter/min)
  3. Oxygen (2 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 3

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (2 Liter/min)
  2. Medical air (MA)
  3. Oxygen (4 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 4

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (2 Liter/min)
  2. Oxygen (4 Liter/min)
  3. Medical air (MA)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 5

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (4 Liter/min)
  2. Medical air (MA)
  3. Oxygen (2 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 6

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (4 Liter/min)
  2. Oxygen (2 Liter/min)
  3. Medical air (MA)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Endurance time (in seconds) measured by endurance shuttle walk test
Time Frame: Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes
Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of breathing frequency during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
measured by NOX-T3 (NoxMedical, Reykjavik, Iceland)
change from baseline to the end of the ESWT, up to 20 minutes
Change of Oxygen saturation during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
change from baseline to the end of the ESWT, up to 20 minutes
Change of heart rate during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
change from baseline to the end of the ESWT, up to 20 minutes
Change of partial pressure of carbon dioxide during endurance shuttle walk test
Time Frame: Change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Time Frame: Change from baseline to the end of the ESWT, up to 20 minutes
measured by Spiropalm 6MWT (Cosmed, Italy)
Change from baseline to the end of the ESWT, up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schön Klinik Berchtesgadener Land

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linde AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPF-O2-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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