Clinical trial NCT02278107: Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
Official title: Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Interstitial Lung Disease
Lead sponsor: New Aera, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-29
Enrollment: 20
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: A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.

Detailed description: An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.

Eligibility criteria: Inclusion Criteria:

* Adult male or female (\> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
* Participates in a qualified pulmonary rehabilitation program
* Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
* Able and willing to sign the informed consent
* Ability to be fitted with the test nasal mask and to use the test ventilator system

Exclusion Criteria:

* Requires \> 5LPM of constant flow to maintain SpO2\> 90% during exercise
* Reports having serious epistaxis within the last 14 days prior to enrollment
* Currently enrolled in another clinical study or has participated within 30 days of enrollment
* Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data

Primary outcomes:
measure: Exercise Endurance Time to Maximum Tolerance
timeFrame: Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Secondary outcomes:
measure: Borg 10 Dyspnea Score, Subject reported
timeFrame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
measure: Arterial Oxygen Saturation via Pulse Oximeter (SpO2)
timeFrame: Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
measure: Leg Fatigue, Subject Reported
timeFrame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
measure: Heart Rate
timeFrame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
measure: Respiratory Rate
timeFrame: Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
measure: Adverse Events
timeFrame: Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.
Other outcomes:
Locations:
Study officials:
affiliation: John Muir Medical Center, Concord Campus
name: Richard Kops, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porszasz J, Cao R, Morishige R, van Eykern LA, Stenzler A, Casaburi R. Physiologic effects of an ambulatory ventilation system in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Aug 1;188(3):334-42. doi: 10.1164/rccm.201210-1773OC.