Clinical trial NCT05267418: Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance
Official title: Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance in Patients With Desaturating Chronic Lung Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Lung Diseases
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Cystic Fibrosis
Interstitial Lung Disease
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.


Eligibility criteria: Inclusion Criteria:

One of them

* Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) ratio \< 0.7)
* Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
* Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure \> 25 mm Hg at right heart catheterization
* Cystic fibrosis, as diagnosed by a positive sweat test (\>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.

AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test \< 88%

Exclusion Criteria:

* Exacerbation of the primary lung disease in the past 8 weeks
* Exercise limiting diseases other than the primary lung disease.
* Not reaching the target dyspnea score during the walking tests.
* Stage 1 pulmonary sarcoidosis
* History of syncope on exertion
* SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
* Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
* Disabling or severe rheumatological or neurological condition
* Participation in a pulmonary rehabilitation program within the last year
* Patients with multi-resistant bacteria

Primary outcomes:
measure: Dyspnea score
timeFrame: At the end of the 3 minute-constant speed shuttle test (CSST) (3 minutes), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)
Secondary outcomes:
measure: Endurance time duration of the Endurance Shuttle Walking Test (EWST)
timeFrame: Duration in (mm:ss) of Endurance Shuttle Walking Test (ESWT), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)
measure: Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)
timeFrame: From the beginning to the end of the Endurance Shuttle Walking Test (ESWT) which will be done on 3 testing days, with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow
Other outcomes:
measure: Mean pulsed O2 saturation (SpO2) during 3min-CSST
timeFrame: From the beginning to the end of the 3 minute-constant speed shuttle test which will be done on 3 testing days with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow)
measure: Capillary blood gases
timeFrame: Difference the baseline capillary PCO2 from the resting values (before Endurance Shuttle Walking Test - ESWT) to the end of exercise values (after the Endurance Shuttle Walking Test - ESWT) immediately after the intervention
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
Study officials:
References:
citation: Maltais F, Aumann JL, Kirsten AM, Nadreau E, Macesic H, Jin X, Hamilton A, O'Donnell DE. Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD. Eur Respir J. 2019 Mar 28;53(3):1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar.
citation: Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau E, Bernard E, Bernard S, Maltais F. Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium versus tiotropium: the RED trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620939507. doi: 10.1177/1753466620939507.
citation: Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9. doi: 10.1080/15412550903156317.