Acute Effects of Oxygen Supplementation Among IPF Patients

September 27, 2018 updated by: Afroditi Boutou, George Papanicolaou Hospital

Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia

Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.

Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • 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 Contact

  • Name: Afroditi Boutou, MD, PhD, MSc
  • Phone Number: 00306946611433
  • Email: afboutou@yahoo.com

Study Locations

      • Thessaloníki, Greece, 57010
        • Recruiting
        • "G. Papanikolaou" General Hospital
        • Contact:

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia

Exclusion Criteria:

  1. Major contraindications for CPET conduction
  2. Not provision of informed consent -

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IPF patients
Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing
Oxygen supplementation (40%) via Venturi mask
Sham Comparator: IPF patients (crossover)
Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing
Medical air supplementation via Venturi mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise duration
Time Frame: through study completion, an average of a year
Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion
through study completion, an average of a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: through study completion, an average of a year
maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing
through study completion, an average of a year
Fatigue
Time Frame: through study completion, an average of a year
maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing
through study completion, an average of a year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oxygenated hemoglobin
Time Frame: through study completion, an average of a year
The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
through study completion, an average of a year
Cardiac output
Time Frame: through study completion, an average of a year
The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing
through study completion, an average of a year

Collaborators and Investigators

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

Investigators

  • Study Chair: Aikaterini Markopoulou, MD, PhD, "G. Papanikolaou" General Hospital, Thessaloniki, Greece

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)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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