Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease

Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease

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.

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.

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