Baseline age and forced vital capacity in one second(FEV1) % predicted normal, and symptoms during run-in
| Symptoms | Patients with exacerbation# | Patients with no exacerbation# | p-values | |
| Age yrs | 64.1 | 64.1 | ||
| FEV1 % pred | 36.3 | 39.3 | ||
| Shortness of breath scores | ||||
| 0 | None: unaware of any difficulty | 6.8 | 13.9 | <0.001 |
| 1 | Mild: noticeable during more strenuous activity, e.g. morning exercises, walking more than one block or up more than one flight without stopping | 25.5 | 29.3 | |
| 2 | Moderate: noticeable during light activity, such as making beds or taking out the garbage, walking one block or up one flight of stairs, running or jogging | 41.7 | 37.6 | |
| 3 | Marked: noticeable when washing or dressing in the morning, after slowly walking less than one block or up to one flight of stairs | 21.0 | 16.7 | |
| 4 | Severe: almost constant, present even when resting | 5.0 | 2.5 | |
| Cough scores | ||||
| 0 | No cough: unaware of coughing | 22.7 | 26.4 | <0.001 |
| 1 | Rare: cough now and then | 34.7 | 34.8 | |
| 2 | Occasional: less than hourly | 27.3 | 26.2 | |
| 3 | Frequent: one or more times an hour | 11.9 | 10.9 | |
| 4 | Almost constant: never free of cough or feeling free of the need to cough | 3.5 | 1.7 | |
| Chest tightness scores | ||||
| 0 | None: unaware of any discomfort | 34.7 | 39.7 | 0.055 |
| 1 | Mild: noticeable now and then, but is not bothersome and passes quickly, does not limit activity | 29.4 | 31.7 | |
| 2 | Moderate: noticeable less than hourly, limits activity and is aggravated or brought on by moderate activity | 22.6 | 21.6 | |
| 3 | Marked: 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 walking | 10.9 | 10.5 | |
| 4 | Severe: almost constant, accompanied by dyspnoea, present even when resting and limits all activity | 1.7 | 2.8 | |
| Night-time awakening scores¶ | ||||
| 0 | Slept through the night | 44.7 | 44.4 | 0.57 |
| 1 | Symptoms caused waking once or early awakening | 23.9 | 26.2 | |
| 2 | Symptoms caused wakening twice or more during the night (including waking early) | 21.1 | 20.4 | |
| 3 | Symptoms caused wakefulness for most of the night | 7.5 | 6.8 | |
| 4 | Symptoms so severe that patient did not sleep at all | 2.7 | 2.2 |
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.