Clinical Trials: Safety and Efficacy

The inCourage™ system meets or exceeds all FDA - mandated safety and efficacy standards

The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of medical devices in the United States. It reviews scientific data meeting defined criteria as a condition for approval. RespirTech has met all FDA requirements to show that the inCourage™ system is both safe (benefits outweigh risks) and effective (it reliably does what it is intended to do). Data to support safety and efficacy includes:

  • device design verification
  • verification and validation studies
  • bench research
  • engineering and/or manufacturing tests
  • statistical risk analyses
  • randomized clinical trials
  • retrospective/prospective
  • observational studies

Safety

The FDA has affirmed the safety of the inCourage™ system based on design, engineering and manufacturing data and clinical trials with generically equivalent HFCC equipment. In more than 25 studies involving over 600 patients, HFCC therapy has proven safe for use by patients with a broad range of acute and chronic conditions complicated by impaired airway clearance function.

  • No studies associated a clinically significant adverse event with HFCC therapy
  • Most patients tolerated and expressed satisfaction with the therapy
  • HFCC has been used safely by more than 70,000 patients

Efficacy

The FDA cleared the inCourage™ system for use among patients who have pulmonary problems associated with inability to evacuate airway secretions without therapeutic intervention. No diagnoses are specified; the inCourage™ system is appropriate for patients at risk for secretion retention regardless of the underlying cause. Dozens of clinical trials demonstrate the clinical efficacy of HFCC therapy in patients with diverse primary and secondary diagnoses.

Selected studies with safety and/or efficacy as an outcome
Cystic Fibrosis:

    Cystic fibrosis (CF) is an inherited disorder characterized by abnormalities in mucus quality, secretion and clearance. Secretions accumulated in the airways harbor infectious organisms and initiate a cascade of events leading to a vicious cycle of progressive lung disease, respiratory failure and ultimately, death. Lifelong daily airway clearance therapy is universally prescribed as medically necessary for all CF patients.

  • Kluft [1996] - 29 subjects with mild to severe CF tolerated HFCC therapy; No adverse effects such as hemoptysis, pneumothorax, respiratory distress or emesis were observed.
  • Braggion [1995] – 16 hospitalized CF patients tolerated HFCC therapy and experienced no adverse events
  • Clayton [1998] – 40 children (mean age 8.9 years) used HFCC for 22 months safely, effectively and adherently (68.1%)
  • Anbar [1999] – Patients with CF sometimes have significant liver pathology. Liver function remained unchanged in 77 patients using HFCC for an average of 8.6 months
Chronic Obstructive Pulmonary Disease
  • Rumbak [2001] – COPD patients showed no HFCC-related adverse events during a 90-day trial study
  • Piquet [1987] – 12 patients with severe COPD showed no HFCC-related adverse events
  • Perry [1998] – 6 COPD patients showed no HFCC-related adverse events
Acute Care/Post-Operative/severe trauma:

    Pulmonary complications arising from transient impairment of mucociliary clearance and cough function are common in post-surgical/acute care patients. Retained secretions promote development of atelectasis, bronchopulmonary infections, pneumonia and respiratory failure. Such complications are a major factor in driving up total healthcare costs, especially in terms of intensive care unit utilization.

  • Allen [2003] 25 elective cardiothoracic surgical patients treated post-operatively with HFCC showed no adverse effects; hemodynamic and pulse oximetry remained stable; 84 % tolerated HFCC well.
  • Brierly [2003] 73 critical care/post surgical patients with invasive or sensitive equipment in place experienced no serious adverse events with HFCC; 84% tolerated HFCC well.
Mechanically Ventilated Patient

    Mechanical ventilation (MV) requires bypassing the upper airway, thus introducing dry air breathing inadequately compensated by the addition of humidifiers and filters. Decreased humidification injures the mucociliary transport system and causes moisture-related changes in mucus viscosity and elasticity. Concomitant ineffective cough may facilitate retrograde movement of secretions to the lung periphery or aspiration from one lung to the other, leading to ventilator-associated pneumonia (VAP). Prolonged dependence on MV diminishes likelihood of successful weaning.

  • Ndukwu [1999] - 54 long-term ventilator-dependent patients received HFCC for 40 days with no adverse events; 38% were successfully weaned from their ventilators.
  • Whitman [1993] – 9 long-term ventilator-dependent patients used HFCC comfortably and safely; hemodynamic parameters remained stable.
  • Gomez [2004] - Atelectasis was safely resolved with HFCC in 4 spinal fusion patients.
Neuromuscular/Neuromotor Disorders:

    Neuromotor and neuromuscular disorders arise from a broad variety of congenital and acquired etiologies; clinical manifestations are equally diverse. In patients with severe disability or advanced disease, respiratory muscle weakness significantly increases risk for pulmonary complications associated with retained airway secretions; respiratory illness is the leading cause of hospitalization and premature death.

  • Giarraffa [2005]
  • Overgaard [2005]
  • Plioplys [2002]

Research and Evidence

Clinical Trials

Research Studies

Annotated Bibliography

Articles