Chronic Obstructive Lung Disease, Interstitial Lung Disease
Conditions
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.
Interventions
DEVICETidal Assist Ventilator System
Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
DEVICENasal Cannula Oxygen
Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.
Sponsors
New Aera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Endurance Time to Maximum Tolerance | 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. | Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Oxygen Saturation via Pulse Oximeter (SpO2) | 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. | SpO2 measured via forehead and finger pulse oximeters |
| Leg Fatigue, Subject Reported | 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. | 10 point Analog scale |
| Borg 10 Dyspnea Score, Subject reported | 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. | 10 point Analog scale |
| Respiratory Rate | 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. | Respiratory rate recorded by observer |
| Adverse Events | 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. | Monitoring for observed or reported adverse reactions |
| Heart Rate | 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. | Heart rate recorded by pulse oximeters |
Outcome results
None listed