Acute Effects of Oxygen Supplementation Among IPF Patients

Overview

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).

Full Title of Study: “Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 1, 2019

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: IPF patients
    • Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing
  • Sham Comparator: IPF patients (crossover)
    • Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Dyspnea
    • Time Frame: 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
  • Fatigue
    • Time Frame: 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

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • George Papanicolaou Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Afroditi Boutou, Consultant in Respiratory Medicine – George Papanicolaou Hospital
  • Overall Official(s)
    • Aikaterini Markopoulou, MD, PhD, Study Chair, “G. Papanikolaou” General Hospital, Thessaloniki, Greece
  • Overall Contact(s)
    • Afroditi Boutou, MD, PhD, MSc, 00306946611433, afboutou@yahoo.com

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