NCT03955770

Brief Summary

This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2019

Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

February 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

May 16, 2019

Last Update Submit

February 5, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Exercise enduranceHigh-flow oxygen therapyLow-flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Exercise endurance time in seconds

    Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

Secondary Outcomes (5)

  • Dyspnea sensation

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

  • Subjective leg fatigue sensation

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

  • Arterial blood gases

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

  • Heart rate in bpm

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

  • Arterial blood pressure in mmHg

    HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization

Study Arms (2)

HFOT first then LFOT

EXPERIMENTAL
Combination Product: High-flow oxygen therapy (HFOT)Combination Product: Low-flow oxygen therapy (LFOT)

LFOT first then HFOT

EXPERIMENTAL
Combination Product: High-flow oxygen therapy (HFOT)Combination Product: Low-flow oxygen therapy (LFOT)

Interventions

High-flow oxygen therapy (HFOT)COMBINATION_PRODUCT

HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher\&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher\&Paykel, New Zealand).

HFOT first then LFOTLFOT first then HFOT
Low-flow oxygen therapy (LFOT)COMBINATION_PRODUCT

LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).

HFOT first then LFOTLFOT first then HFOT

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC \<0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 \<6 kPa at 760 m) who live \<800 m will be invited.

You may not qualify if:

  • COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92%), current heavy smoking (\>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Location

Related Publications (1)

  • Bitos K, Furian M, Mayer L, Schneider SR, Buenzli S, Mademilov MZ, Sheraliev UU, Marazhapov NH, Abdraeva AK, Aidaralieva SD, Muratbekova AM, Sooronbaev TM, Ulrich S, Bloch KE. Effect of High-Flow Oxygen on Exercise Performance in COPD Patients. Randomized Trial. Front Med (Lausanne). 2021 Feb 19;7:595450. doi: 10.3389/fmed.2020.595450. eCollection 2020.

    PMID: 33693009DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Furian, PhD

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

  • Konrad E Bloch, MD

    University of Zurich

    STUDY CHAIR

  • Talant M Sooronbaev, MD

    National Center of Cardiology and Internal Medicine, Bishkek

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

May 20, 2019

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

February 6, 2020

Record last verified: 2020-01

Locations

KY(1)