Inhalation in Asthma and COPD With Spiromax and Turbuhaler
Demographics and baseline characteristics of the study participants are shown in Table 1. None of these individuals withdrew prematurely before completing the study. The mean ACQ score was 1.62 (standard deviation, SD, 0.95) for children with asthma (aged 6–11 years), 1.66 (0.97) for adolescents with asthma and 1.85 (0.90) for adults with asthma. Seven percent of all of the asthma patients had well controlled disease (ACQ score <0.7), 48% had partly controlled asthma (ACQ score 0.7–1.5) and 45% had poorly controlled disease (ACQ score >1.5). The majority of COPD patients had BDI grade 3 (18 subjects, 36%) or grade 4 (16 subjects, 32%); the remainder had grade 2 (n = 8) or grade 5 (n = 8).
Salbutamol was taken by >90% of the patients with asthma and by 82% of those with COPD. Percentages of salbutamol recipients receiving the drug via an MDI (with or without a spacer) were as follows: 100% of the children with asthma, 85%; of the adolescents with asthma, 80%; of the adults with asthma, and 60% of the 80%; COPD patients.
Other medications used by asthma patients were Seretide™ Accuhaler™ (34.8–52%) and Symbicort Turbuhaler (30.4–51.9%). Of the COPD patients, 74% were prescribed salbutamol.
The internal resistance of the empty Spiromax device was 0.100 (cmH20)½ (l/min) (equivalent to 0.0313 kPa½ (l/min)), which is similar to the resistance of the commercially available Spiromax device. The internal resistance of the Turbuhaler device used was 0.107 (cmH20)½ (l/min) (equivalent to 0.0355 kPa½ (l/min)) and this is similar to commercially available Symbicort® Turbuhaler.
PIF, maximum change in pressure (ΔP) and inhalation volume (IV) were significantly higher with Spiromax than with the Turbuhaler device (Table 2). Differences between the two inhalers in PIF were highly significant in all five study groups (p ≤ 0.0001), while statistical significance (p < 0.05) was observed with maximum ΔP in the four patient groups. No statistical difference was observed for maximum ΔP in the healthy adult group for Spiromax versus Turbuhaler. Distributions of individual patient values for PIF, maximum ΔP and IV are depicted in Figure 3. Pre-training, there were trends towards slightly higher inspiratory ACC with Spiromax, with statistically significant differences in the COPD and healthy adult groups (Table 2). Figure 3a shows that post-PIL training, one adult with asthma and one COPD patient inhaled <30 L/min with Spiromax and that one adult with asthma and five patients with COPD inhaled <30 L/min with the Turbuhaler. IV was also significantly higher with Spiromax versus Turbuhaler in all study groups.
(Enlarge Image)
Figure 3.
Individual peak inspiratory flow rates (A), maximum pressure change (ΔP) (B) and inhalation volume (C) before enhanced training. In graph (A), the horizontal dotted line represents 30 L/min (minimal flow for adequate drug delivery).
Mean time to PIF was generally similar for the two devices, ranging between 0.61 and 1.02 seconds across the five study groups with Spiromax and between 0.79 and 1.19 seconds with Turbuhaler (data not shown). The only group with a significant difference in time to PIF was COPD patients, where it was significantly shorter with Spiromax (0.68 vs 0.96 seconds, p = 0.0135). In each study group, Ti was similar with both devices; the range of mean values across the five study groups was 1.81–2.94 seconds with the Spiromax device and 1.94–3.02 seconds with Turbuhaler.
Enhanced training, when compared to standard PIL training, significantly improved PIF, ACC, maximum ΔP and IV (p < 0.05) in all study groups and with both inhalers. Percentage improvements following enhanced training were slightly larger with Turbuhaler than with Spiromax (Table 3). With both devices, the parameter with the highest percentage improvements in response to enhanced training was ACC (Table 3). IV was the parameter with the smallest percentage improvements.
After enhanced training, PIF remained significantly higher with Spiromax versus Turbuhaler in all study groups (p < 0.01; Table 3). Numerically or significantly higher values with Spiromax versus Turbuhaler were also observed for maximum ΔP, ACC and IV after enhanced training, with the exception of maximum ΔP in COPD patients (Table 3). Time to PIF was shorter with both devices after enhanced training, with study group mean values ranging between 0.48 and 0.56 seconds with Spiromax, and between 0.43 and 0.56 seconds with Turbuhaler. There were no significant post-training differences between the devices in time to PIF for any of the study groups. Slight reductions were apparent in Ti post-training, but mean values remained similar with both devices.
Results
Study Participants
Demographics and baseline characteristics of the study participants are shown in Table 1. None of these individuals withdrew prematurely before completing the study. The mean ACQ score was 1.62 (standard deviation, SD, 0.95) for children with asthma (aged 6–11 years), 1.66 (0.97) for adolescents with asthma and 1.85 (0.90) for adults with asthma. Seven percent of all of the asthma patients had well controlled disease (ACQ score <0.7), 48% had partly controlled asthma (ACQ score 0.7–1.5) and 45% had poorly controlled disease (ACQ score >1.5). The majority of COPD patients had BDI grade 3 (18 subjects, 36%) or grade 4 (16 subjects, 32%); the remainder had grade 2 (n = 8) or grade 5 (n = 8).
Asthma or COPD Medication use Reported at Start of Study
Salbutamol was taken by >90% of the patients with asthma and by 82% of those with COPD. Percentages of salbutamol recipients receiving the drug via an MDI (with or without a spacer) were as follows: 100% of the children with asthma, 85%; of the adolescents with asthma, 80%; of the adults with asthma, and 60% of the 80%; COPD patients.
Other medications used by asthma patients were Seretide™ Accuhaler™ (34.8–52%) and Symbicort Turbuhaler (30.4–51.9%). Of the COPD patients, 74% were prescribed salbutamol.
Device Characteristics
The internal resistance of the empty Spiromax device was 0.100 (cmH20)½ (l/min) (equivalent to 0.0313 kPa½ (l/min)), which is similar to the resistance of the commercially available Spiromax device. The internal resistance of the Turbuhaler device used was 0.107 (cmH20)½ (l/min) (equivalent to 0.0355 kPa½ (l/min)) and this is similar to commercially available Symbicort® Turbuhaler.
Inhalation Parameters After Standard PIL Training
PIF, maximum change in pressure (ΔP) and inhalation volume (IV) were significantly higher with Spiromax than with the Turbuhaler device (Table 2). Differences between the two inhalers in PIF were highly significant in all five study groups (p ≤ 0.0001), while statistical significance (p < 0.05) was observed with maximum ΔP in the four patient groups. No statistical difference was observed for maximum ΔP in the healthy adult group for Spiromax versus Turbuhaler. Distributions of individual patient values for PIF, maximum ΔP and IV are depicted in Figure 3. Pre-training, there were trends towards slightly higher inspiratory ACC with Spiromax, with statistically significant differences in the COPD and healthy adult groups (Table 2). Figure 3a shows that post-PIL training, one adult with asthma and one COPD patient inhaled <30 L/min with Spiromax and that one adult with asthma and five patients with COPD inhaled <30 L/min with the Turbuhaler. IV was also significantly higher with Spiromax versus Turbuhaler in all study groups.
(Enlarge Image)
Figure 3.
Individual peak inspiratory flow rates (A), maximum pressure change (ΔP) (B) and inhalation volume (C) before enhanced training. In graph (A), the horizontal dotted line represents 30 L/min (minimal flow for adequate drug delivery).
Mean time to PIF was generally similar for the two devices, ranging between 0.61 and 1.02 seconds across the five study groups with Spiromax and between 0.79 and 1.19 seconds with Turbuhaler (data not shown). The only group with a significant difference in time to PIF was COPD patients, where it was significantly shorter with Spiromax (0.68 vs 0.96 seconds, p = 0.0135). In each study group, Ti was similar with both devices; the range of mean values across the five study groups was 1.81–2.94 seconds with the Spiromax device and 1.94–3.02 seconds with Turbuhaler.
Effects of Enhanced Training
Enhanced training, when compared to standard PIL training, significantly improved PIF, ACC, maximum ΔP and IV (p < 0.05) in all study groups and with both inhalers. Percentage improvements following enhanced training were slightly larger with Turbuhaler than with Spiromax (Table 3). With both devices, the parameter with the highest percentage improvements in response to enhanced training was ACC (Table 3). IV was the parameter with the smallest percentage improvements.
After enhanced training, PIF remained significantly higher with Spiromax versus Turbuhaler in all study groups (p < 0.01; Table 3). Numerically or significantly higher values with Spiromax versus Turbuhaler were also observed for maximum ΔP, ACC and IV after enhanced training, with the exception of maximum ΔP in COPD patients (Table 3). Time to PIF was shorter with both devices after enhanced training, with study group mean values ranging between 0.48 and 0.56 seconds with Spiromax, and between 0.43 and 0.56 seconds with Turbuhaler. There were no significant post-training differences between the devices in time to PIF for any of the study groups. Slight reductions were apparent in Ti post-training, but mean values remained similar with both devices.
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