Acute Effects of Oxygen Supplementation Among IPF Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03688334
• Other study ID #: 804/2018
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2018
• Source: George Papanicolaou Hospital
• Contact: Afroditi Boutou, MD, PhD, MSc
• Phone: 00306946611433
• Email: afboutou[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Oxygen 40 %
Oxygen supplementation (40%) via Venturi mask
• Medical air (sham O2)
Medical air supplementation via Venturi mask

Locations

Country	Name	City	State
Greece	"G. Papanikolaou" General Hospital	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral oxygenated hemoglobin	The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing	through study completion, an average of a year
Other	Cardiac output	The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing	through study completion, an average of a year
Primary	Exercise duration	Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion	through study completion, an average of a year
Secondary	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	through study completion, an average of a year
Secondary	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	through study completion, an average of a year