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Clinical Study - Diagnostic Application

Two clinical studies were conducted with 20 and 15 COPD subjects respectively

  • School of Medicine, University at Buffalo (SUNY)
  • VA Western NY Healthcare System
  • Sanjay Sethi, MD (PI)

Purpose

  • Safety and efficacy of sputum induction with the Lung Flute® was compared with sputum induction with hypertonic saline and saliva

  • Biological markers were measured which indicate the presence of lower respiratory secretions:

    • Study I & II

      • Gram Stain
      • Fibrinogen Content
      • Interleukin-8 Content
      • Free Neutrophil Elastase Activity

    • Study II

      • Total Cell Count
      • Neutrophil Count
      • Macrophage Count
      • Squamous Cell Count

Results

  • Sputum induction with Lung Flute® was as good as hypertonic saline on all four measures

    • No statistical difference

  • Lung Flute® was statistically better than saliva on three of four characteristics

    • Gram stain
    • Fibrinogen content
    • Interleukin-8 content
    • No statistically significant difference was observed in free Neutrophil Elastase activity

  • All 20 Lung Flute® samples had at least 1 out of 4 markers indicative of lower respiratory tract secretions

  • Safety was measured immediately after induction and 24 hours later

      Lung Flute® Hypertonic Saline
    Bronchospasms 1/20 10/20*

    * 9/10 required treatment with a beta 2 agonist

Conclusions

  • Sputum induction is safe in COPD, including very severe COPD

  • Sputum induction with the Lung Flute® is successful in obtaining lower respiratory tract secretions

  • Sputum samples obtained by induction with the Lung Flute® are comparable to samples obtained by induction with hypertonic saline

  • Sputum induction with the Lung Flute® is safer, less time consuming, more convenient and tolerated better by patients than induction with hypertonic saline