Idiopathic Pulmonary Fibrosis
Conditions
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).
Interventions
DRUGOxygen 40 %
Oxygen supplementation (40%) via Venturi mask
DRUGMedical air (sham O2)
Medical air supplementation via Venturi mask
Sponsors
George Papanicolaou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
1. Major contraindications for CPET conduction 2. Not provision of informed consent -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise duration | through study completion, an average of a year | Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | 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 | 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 |
Countries
Greece
Contacts
STUDY_CHAIRAikaterini Markopoulou, MD, PhD
"G. Papanikolaou" General Hospital, Thessaloniki, Greece
Outcome results
None listed