Table. 1—

Baseline age and forced vital capacity in one second(FEV1) % predicted normal, and symptoms during run-in

SymptomsPatients with exacerbation#Patients with no exacerbation#p-values
Age yrs64.164.1
FEV1 % pred36.339.3
Shortness of breath scores
 0None: unaware of any difficulty6.813.9<0.001
 1Mild: noticeable during more strenuous activity, e.g. morning exercises, walking more than one block or up more than one flight without stopping25.529.3
 2Moderate: noticeable during light activity, such as making beds or taking out the garbage, walking one block or up one flight of stairs, running or jogging41.737.6
 3Marked: noticeable when washing or dressing in the morning, after slowly walking less than one block or up to one flight of stairs21.016.7
 4Severe: almost constant, present even when resting5.02.5
Cough scores
 0No cough: unaware of coughing22.726.4<0.001
 1Rare: cough now and then34.734.8
 2Occasional: less than hourly27.326.2
 3Frequent: one or more times an hour11.910.9
 4Almost constant: never free of cough or feeling free of the need to cough3.51.7
Chest tightness scores
 0None: unaware of any discomfort34.739.70.055
 1Mild: noticeable now and then, but is not bothersome and passes quickly, does not limit activity29.431.7
 2Moderate: noticeable less than hourly, limits activity and is aggravated or brought on by moderate activity22.621.6
 3Marked: noticeable one or more times an hour, may be accompanied by dyspnoea, limits activity and is aggravated or brought on by normal activity, such as walking10.910.5
 4Severe: almost constant, accompanied by dyspnoea, present even when resting and limits all activity1.72.8
Night-time awakening scores
 0Slept through the night44.744.40.57
 1Symptoms caused waking once or early awakening23.926.2
 2Symptoms caused wakening twice or more during the night (including waking early)21.120.4
 3Symptoms caused wakefulness for most of the night7.56.8
 4Symptoms so severe that patient did not sleep at all2.72.2
  • Data presented as % unless otherwise stated. #: per cent of days during the run-in period in which the indicated score was recorded for patients with and without event-based exacerbations; : due to respiratory symptoms.