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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

From: The safety and efficacy of inhaled dry powder mannitol as a bronchial provocation test for airway hyperresponsiveness: a phase 3 comparison study with hypertonic (4.5%) saline

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