Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis

Table 1 Symptoms and signs of a pulmonary exacerbation of CF^a

Symptoms	Signs
increased sputum, cough, dyspnea	10% drop in FEV₁ or forced vital capacity
chest pain or tightness	Temperature > 38.4 °C
hemoptysis	Witnessed hemoptysis greater than 100 ml per episode
fever	SaO₂ < 90% or PaO₂ < 60 mmHg despite usual oxygen
chills	For adolescents a drop in SaO₂ of 5% (for example, 97 to 92%)
arthralgias	Increased supplemental oxygen requirements
fatigue	Unplanned weight loss ≥5% of baseline body weight over 3 months
Other Considerations
Respiratory arrest or failure requiring mechanical ventilation regardless of other criteria At site PI discretion for borderline cases or for cases with serious findings not included here

^aA pulmonary exacerbation is defined as the presence of one symptom and one objective finding

ISSN: 1471-2288