Table 5 Vital signs at baseline (before pre challenge spirometry), and the change (Δ) at end of challenge and during recovery for the safety population
Parameter | Challenge Point | Mannitol | Hypertonic Saline |
|---|---|---|---|
n | 627 | 636 | |
Heart Rate (beats/ minute) | Baseline | 75.9 ± 13.4 | 76.2 ± 13.6 |
End Challenge | Δ7.2 ± 10.8 | Δ5.4 ± 9.2 | |
Recovery to pre Challenge FEV1 or 15 min post Challenge | Δ1.6 ± 10.0 | Δ0.7 ± 9.3 | |
Respiration Rate (per min) | Baseline | 17.1 ± 4.3 | 17.1 ± 4.3 |
End Challenge | Δ1.0 ± 3.3 | Δ1.1 ± 3.7 | |
Recovery to pre Challenge FEV1 or 15 min post Challenge | Δ0.1 ± 2.9 | Δ0.2 ± 3.0 | |
Systolic Blood Pressure | Baseline | 117.0 ± 14.8 | 116.9 ± 14.6 |
mm Hg | End Challenge | Δ1.5 ± 9.5 | Δ1.5 ± 9.2 |
Recovery to pre Challenge FEV1 or 15 min post Challenge | Δ-0.1 ± 8.8 | Δ0.5 ± 9.1 | |
Diastolic Blood Pressure | Baseline | 72.0 ± 10.0 | 72.6 ± 10.2 |
mmHg | End Challenge | Δ2.4 ± 7.5 | Δ1.7 ± 7.4 |
Recovery to pre Challenge FEV1 or 15 min post Challenge | Δ1.2 ± 7.0 | Δ0.4 ± 7.3 | |
% oxygen saturation by | Baseline | 97.2 ± 1.8 | 97.5 ± 1.6 |
pulse oximeter | End Challenge | Δ0.8 ± 2.0 | Δ-0.7 ± 1.9 |
Recovery to pre Challenge FEV1 or 15 min post Challenge | Δ-0.4 ± 1.6 | Δ-0.1.4 ± 1.6 |