Figures
- Fig. 1.—
Suggested abbreviated protocol. Patients with baseline ratio (BR) ≥80% of predicted, are separated for the initial inhalation step, beyond which the protocol is identical for both groups. *: the next step can follow if the change from baseline forced expiratory volume in one second (ΔFEV1)<10%. ×: Methacholine Challenge Test (MCT) not performed; ✓: MCT performed; IPP: Initial patient population; BR: baseline ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVCbl).
Tables
- Table 1—
Patient anthropometric data and baseline values
FEV1/FVCbl Total ≥0.8 <0.8 Subjects n 280 169 449 Male 153 (55) 94 (56) 247 (55) Age yrs 19 (6–72) 26 (7–84) 19 (6–84) FEV1 % pred 94.3±11.3 88.9±12.7 92.2±11.9 FEF50 % pred 94.3±18.4 66.2±12.9 83.7±21.3 Positive responders 155 (55.4) 113 (66.7) 268 (59.7) PD20 µmol 1.50 (0.14–17.05) 0.94 (0.05–17.31) 1.24 (0.08–17.82) -
Data presented as mean±sd, n (%) or mean (range), except where stated. FEV1: forced expiratory volume in one second; FEV1/FVCbl: baseline ratio of FEV1 to forced vital capacity; % pred: percentage of the predicted value; FEF50: forced expiratory flow at 50% of vital capacity; PD20: provocative dose causing a 20% fall in FEV1
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data presented as geometric mean (95% confidence interval)
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- Table 2—
Outcome of the simulated methacholine three-fold dose protocol
Cumulative dose µmol Total responders i.e. ΔFEV1>20% Moderate responders i.e. <ΔFEV1 30–40% Severe responders i.e. ΔFEV1>40% 0.073 5 (3.0) 1 (0.2) 2 (0.4) 0.126* 1 (0.6)* 0* 0* 0.219 12 (2.7) 0 0 0.379* 17 (3.8)* 1 (0.2)* 0* 0.657 18 (4.0) 6 (1.3) 2 (0.4) 1.137* 35 (7.8)* 8 (1.8)* 1 (0.2)* 1.970 34 (7.6) 5 (1.1) 4 (0.8) 3.412* 30 (6.7)* 7 (1.6)* 0* 5.910 42 (9.4) 16 (3.6) 4 (0.8) 10.237* 32 (7.1)* 5 (1.1)* 1 (0.2)* 17.731 42 (9.4) 3 (0.7) 1 (0.2) Total 268 (59.7) 52 (11.6) 15 (3.3) -
Data are presented as number of subjects (percentage of subjects participating at that dose) at each inhalation step, including intermediate steps (indicated by *)
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since only 169 subjects would have participated in these steps, percentages are out of 169
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ΔFEV1: the percentage change in forced expiratory volume in one second from baseline
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- Table 3—
Outcomes of the simulated methacholine three-fold dose protocol for separate groups during early protocol steps
Cumulative dose µmol FEV1/FVCbl <0.8 (n=169) FEV1/FVCbl ≥0.8 (n=280) ΔFEV1 30–40% ΔFEV1 >40% ΔFEV1 30–40% ΔFEV1 >40% 0.073 1 (0.6) 2 (1.2) nd nd 0.126* 0* 0* nd nd 0.219 0 0 0 0 -
Data are presented as number of subjects (percentage of subjects participating at that dose) at each inhalation step, including intermediate steps (indicated by *). ΔFEV1: the percentage change in forced expiratory volume in one second from baseline; FEV1/FVCbl: baseline ratio of forced expiratory volume to forced vital capacity; nd: not determined.
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