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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03688334
Other study ID # 804/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 -

Study Design


Related Conditions & MeSH terms


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
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