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Acute Effects of Oxygen Supplementation Among IPF Patients

NCT ID: NCT03688334

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-01

Brief Summary

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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).

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IPF patients

Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing

Group Type ACTIVE_COMPARATOR

Oxygen 40 %

Intervention Type DRUG

Oxygen supplementation (40%) via Venturi mask

IPF patients (crossover)

Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing

Group Type SHAM_COMPARATOR

Medical air (sham O2)

Intervention Type DRUG

Medical air supplementation via Venturi mask

Interventions

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Oxygen 40 %

Oxygen supplementation (40%) via Venturi mask

Intervention Type DRUG

Medical air (sham O2)

Medical air supplementation via Venturi mask

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Papanicolaou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Afroditi Boutou

Consultant in Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aikaterini Markopoulou, MD, PhD

Role: STUDY_CHAIR

"G. Papanikolaou" General Hospital, Thessaloniki, Greece

Locations

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"G. Papanikolaou" General Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Afroditi Boutou, MD, PhD, MSc

Role: CONTACT

Phone: 00306946611433

Email: [email protected]

Facility Contacts

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Afroditi Boutou, MD, MSc, PhD

Role: primary

Other Identifiers

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804/2018

Identifier Type: -

Identifier Source: org_study_id