Acute Effects of Oxygen Supplementation Among IPF Patients

Not Applicable

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Oxygen 40 %; Drug: Medical air (sham O2)

• Registration Number: NCT03688334
• Lead Sponsor: George Papanicolaou Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-27
• Last Update Submitted: 2018-09-27
• Study First Posted: 2018-09-28
• Last Update Posted: 2018-09-28
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPF patients	Oxygen 40 %	Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing
IPF patients (crossover)	Medical air (sham O2)	Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

Primary Outcome Measures

Name	Time	Method
Exercise duration	through study completion, an average of a year	Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion

Secondary Outcome Measures

Name	Time	Method
Fatigue	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
Dyspnea	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

Trial Locations

Locations (1)

"G. Papanikolaou" General Hospital; 🇬🇷 Thessaloníki, Greece