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Torrance, California 90502


Purpose:

Pilot study in 10 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies ventilation system on respiratory mechanics during constant work rate exercise in subjects with severe COPD. Two healthy male control subjects will also be evaluated in orde to validate the data collection system.


Study summary:

Subjects will participate in randomized partially blinded series of exercises at their constant work rate while using the Breathe Technologies ventilation system. Subjects will be assessed for pulmonary mechanics and gas exchange during constant work rate exercise as reflected by changes in the log amplitude of respiratory muscle EMG (intercostal, scalene and diaphragm) and chest wall to abdominal synchrony as measured by respiratory inductance plethysmography. Two healthy male control subjects will be evaluated in order to validate the data collection system. The exercises will take place over 3-4 visits with each visit lasting approximately 5 hours. Subjects may discontinue study participation at any time.


Criteria:

Inclusion Criteria for Healthy Subjects - Adult males, ≥ 18 years of age at screening - Currently in good general health as assessed by medical history and cardiopulmonary physical examination - Willingness and ability to perform all study related procedures and tasks - Ability to be properly fitted with the Breathe nasal mask - Ability to use the Breathe ventilator system - Ability to be properly fitted with an exercise mask - Fluency in written and spoken English - Provision of written informed consent Inclusion Criteria for Subjects with COPD - Adult males, ≥ 40 years of age - Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 < 50% of predicted and an FEV1/FVC ratio < 70% of predicted - Ventilatory limitation to exercise, documented by a VE/MVV > 0.85 - SpO2 between 80% and 88% during incremental exercise testing on room air - Willingness and ability (after training) to exercise on a cycle ergometer - Willingness and ability to perform all other study related procedures and tasks - Ability to be properly fitted with the Breathe nasal mask - Ability to tolerate and be appropriately titrated on the Breathe ventilator (See Appendix E) - Ability to be properly fitted with an exercise mask - Fluency in written and spoken English - Provision of written informed consent Exclusion Criteria for Healthy Subjects - History of chronic illness or medical condition(s) that in the opinion of the Principal Investigator makes the subject unsuitable for study participation - Use of prescription medication(s) 30 days prior to screening, except as approved by the Principal Investigator - Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance - Current participation in another interventional study or participation within 14 days of screening - Presence of any condition or abnormality that in the opinion of the Principal Investigator may compromise the subject's safety or the quality of the study data Exclusion Criteria for Subjects with COPD - History of acute exacerbation of COPD within 30 days of screening - History of serious epistaxis within 14 days of screening - Requirement of > 5 LPM nasal O2 to maintain an SpO2 > 90% while at rest - History of pneumothorax secondary to lung bullae - History of intolerance to supplemental oxygen - Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance - Inability to achieve an optimal CWR level (4-7 minutes) during Study Visit 1R - Current participation in another interventional study or participation within 14 days of screening - Presence of any condition or abnormality that in the opinion of the Principal Investigator may compromise the subject's safety or the quality of the study data


NCT ID:

NCT01372462


Primary Contact:

Principal Investigator
Richard Casaburi, Ph.D., M.D.
Los Angeles Biomedical Research Institute


Backup Contact:

N/A


Location Contact:

Torrance, California 90502
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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