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Acute Effects of Oxygen Supplementation Among IPF Patients

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ClinicalTrials.gov Identifier: NCT03688334
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Afroditi Boutou, 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).


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Oxygen 40 % Drug: Medical air (sham O2) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019


Arm Intervention/treatment
Active Comparator: IPF patients
Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing
Drug: Oxygen 40 %
Oxygen supplementation (40%) via Venturi mask

Sham Comparator: IPF patients (crossover)
Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing
Drug: Medical air (sham O2)
Medical air supplementation via Venturi mask




Primary Outcome Measures :
  1. Exercise duration [ Time Frame: through study completion, an average of a year ]
    Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Cerebral oxygenated hemoglobin [ Time Frame: through study completion, an average of a year ]
    The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing

  2. Cardiac output [ Time Frame: through study completion, an average of a year ]
    The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688334


Contacts
Contact: Afroditi Boutou, MD, PhD, MSc 00306946611433 afboutou@yahoo.com

Locations
Greece
"G. Papanikolaou" General Hospital Recruiting
Thessaloníki, Greece, 57010
Contact: Afroditi Boutou, MD, MSc, PhD    00306946611433    afboutou@yahoo.com   
Sponsors and Collaborators
George Papanicolaou Hospital
Investigators
Study Chair: Aikaterini Markopoulou, MD, PhD "G. Papanikolaou" General Hospital, Thessaloniki, Greece

Responsible Party: Afroditi Boutou, Consultant in Respiratory Medicine, George Papanicolaou Hospital
ClinicalTrials.gov Identifier: NCT03688334     History of Changes
Other Study ID Numbers: 804/2018
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial