Acute Effects of Oxygen Supplementation Among IPF Patients

NCT03688334 | Completed

• 1 other identifier: 804/2018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Exercise duration

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

  through study completion, an average of a year

Secondary Outcomes (2)

• Dyspnea

  through study completion, an average of a year

• Fatigue

  through study completion, an average of a year

Other Outcomes (2)

• Cerebral oxygenated hemoglobin

  through study completion, an average of a year

• Cardiac output

  through study completion, an average of a year

Study Arms (2)

IPF patients

ACTIVE COMPARATOR

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

Drug: Oxygen 40 %

IPF patients (crossover)

SHAM COMPARATOR

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

Drug: Medical air (sham O2)

Interventions

Oxygen 40 % DRUG

Oxygen supplementation (40%) via Venturi mask

IPF patients

Medical air (sham O2) DRUG

Medical air supplementation via Venturi mask

IPF patients (crossover)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• George Papanicolaou Hospital: lead

Study Sites (1)

"G. Papanikolaou" General Hospital

Thessaloniki, 57010, Greece

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Air

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Aikaterini Markopoulou, MD, PhD

  "G. Papanikolaou" General Hospital, Thessaloniki, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Respiratory Medicine

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)