Back to results

Acute Effects of Oxygen Supplementation Among IPF Patients

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status

Unknown status

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Oxygen 40 %

Medical air (sham O2)

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Major contraindications for CPET conduction
Not provision of informed consent -

Sites / Locations

"G. Papanikolaou" General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

IPF patients

IPF patients (crossover)

Arm Description

Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing

Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

Outcomes

Primary Outcome Measures

Exercise duration

Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion

Secondary Outcome Measures

Dyspnea

maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing

Fatigue

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

Full Information

NCT ID

NCT03688334

First Posted

September 20, 2018

Last Updated

September 27, 2018

Sponsor

George Papanicolaou Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03688334

Brief Title

Acute Effects of Oxygen Supplementation Among IPF Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Anticipated)

Study Completion Date

June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

George Papanicolaou Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IPF patients

Arm Type

Active Comparator

Arm Description

Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing

Arm Title

IPF patients (crossover)

Arm Type

Sham Comparator

Arm Description

Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

Intervention Type

Drug

Intervention Name(s)

Oxygen 40 %

Intervention Description

Oxygen supplementation (40%) via Venturi mask

Intervention Type

Drug

Intervention Name(s)

Medical air (sham O2)

Intervention Description

Medical air supplementation via Venturi mask

Primary Outcome Measure Information:

Title

Exercise duration

Description

Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion

Time Frame

through study completion, an average of a year

Secondary Outcome Measure Information:

Title

Dyspnea

Description

maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing

Time Frame

through study completion, an average of a year

Title

Fatigue

Description

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

Time Frame

through study completion, an average of a year

Other Pre-specified Outcome Measures:

Title

Cerebral oxygenated hemoglobin

Description

The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing

Time Frame

through study completion, an average of a year

Title

Cardiac output

Description

The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing

Time Frame

through study completion, an average of a year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Major contraindications for CPET conduction Not provision of informed consent -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Afroditi Boutou, MD, PhD, MSc

Phone

00306946611433

afboutou@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aikaterini Markopoulou, MD, PhD

Organizational Affiliation

"G. Papanikolaou" General Hospital, Thessaloniki, Greece

Official's Role

Study Chair

Facility Information:

Facility Name

"G. Papanikolaou" General Hospital

City

Thessaloníki

ZIP/Postal Code

57010

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Afroditi Boutou, MD, MSc, PhD

Phone

00306946611433

afboutou@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acute Effects of Oxygen Supplementation Among IPF Patients

We'll reach out to this number within 24 hrs