Clinical Trials and Centralized DLCO Testing

According to the American Thoracic Society (ATS), “Measuring an ‘overall’ CO uptake by single-breath technique has proved useful in assessing a variety of lung abnormalities that impair alveolar capillary gas transport. Moreover, in many diseases, the magnitude of abnormalities in DLCO has been shown to correlate with disease severity and with direct measurements of aterial blood oxygenation, especially during exercise.”†
^{†American Thoracic Society, Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor) Recommendation for a Standard Technique}

Centralized DLCO testing offers Sponsors the advantage of being able to diagnose and treat lung disorders not found by either spirometry or chest x-ray. When DLCO is used for clinical screening of patients with some types of lung disease, testing can demonstrate a significantly impaired gas exchange in many patients where no significant defect in mechanics of breathing (spirometry) were found. Many of these patients may also have a normal chest x-ray so that only reduced DLCO offers valid proof of lung disease.

At the onset of a clinical trial, Biomedical Systems’ centralized approach encompasses:
• Standardized DLCO simulator and software,
   accessories and disposable supplies
• Training for site personnel conducted on-site, at
   investigator meeting or by teleconference
• Protocol specific training manuals and quickguides
• 24/7 technical support throughout the trial