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Tuberc Respir Dis > Volume 85(1); 2022 > Article |
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Authors’ Contributions
Conceptualization: Kang SY, Lee SM, Kim TB, Lee SP. Methodology: Kang SY, Lee SM, Kim TB, Lee SP. Formal analysis: Nam TH, Kang SY, Lee SM, Kim TB, Lee SP. Data curation: Kang SY, Lee SM. Writing - original draft preparation: Nam TH, Kang SY, Lee SM. Writing - review and editing: Nam TH, Kang SY, Lee SM, Kim TB, Lee SP. Approval of final manuscript: all authors.
Values are presented as number (%) or median (interquartile ranges). We compared continuous variables between groups using the Mann-Whitney U test and analyzed categorical variables using the chi-square test or Fisher’s exact test.
ITT: intention to treat; PP: per protocol; FORM: formoterol; BDP: beclomethasone dipropionate; BUD: budesonide; BMI: body mass index; AHR: airway hyperresponsiveness; MCT: methacholine challenge test; BDR: bronchodilator response; TR: treatment response; ACT: Asthma Control Test; ACQ: Asthma Control Questionnaire; QLQAKA: Quality of Life Questionnaire for Adult Korean Asthmatics; OPD: outpatient department; ER: emergency room; ICU: intensive care unit; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 second; FEF25-75: forced expiratory flow at 25% to 75% of forced vital capacity; FeNO: fractional nitric oxide concentration in exhaled breath; ICS: inhaled corticosteroid; LABA: long-acting beta2 agonist; pMDI: pressurized metered-dose inhaler.
Total (n=24) | FORM/BDP group (n=10) | FORM/BUD group (n=14) | p-value | ||
---|---|---|---|---|---|
Asthma control (after 4-week treatment) | 0.664 | ||||
Well controlled | 17 (70.8) | 7 (70.0) | 10 (71.4) | ||
Partly controlled | 3 (12.5) | 1 (10.0) | 2 (15.4) | ||
Uncontrolled | 4 (16.7) | 2 (20.0) | 2 (15.4) | ||
Asthma control (after 8-week treatment) | 0.556 | ||||
Well controlled | 15 (62.5) | 5 (50.0) | 10 (71.4) | ||
Partly controlled | 7 (29.2) | 4 (40.0) | 3 (21.4) | ||
Uncontrolled | 2 (8.3) | 1 (10.0) | 1 (7.1) | ||
ACT change from baseline | 0.5 (-2.0 to 5.8) | -1.5 (-2.5 to 5.5) | 1.5 (-2.0 to 6.0) | 0.443 | |
ACQ change from baseline | 0.0 (-0.6 to 0.5) | 0.4 (-0.6 to 0.8) | -1.0 (-4.5 to 2.0) | 0.095 | |
QLQAKA change from baseline | -15.5 (-20.5 to -7.5) | -14.0 (-17.5 to -5.5) | -17.0 (-21.0 to -6.0) | 0.752 | |
Lung function | |||||
FVC change, % of baseline | 1.5 (-8.8 to 12.1) | 1.9 (-11.6 to 31.3) | 0.9 (-6.6 to 7.0) | 0.554 | |
FEV1 change, % of baseline | 1.4 (-7.0 to 13.9) | 1.8 (-2.1 to 55.6) | -2.2 (-7.9 to 11.5) | 0.193 | |
FEF25-75 change, % of baseline | 11.3 (-10.3 to 30.5) | 17.9 (3.5 to 128.2) | 2.9 (-16.4 to 17.9) | 0.037* | |
FEV1/FVC change, % | 1.0 (-1.0 to 5.0) | 3.0 (1.0 to 13.5) | 1.0 (-3.8 to 3.8) | 0.043* | |
FeNO change from baseline, ppb | 1.0 (-34.0 to 31.0) | 1.0 (-25.0 to 5.0) | -1.5 (-58.0 to 37.8) | >0.99 | |
Compliance to inhaler, % | 80.4 (70.6 to 94.2) | 78.4 (68.4 to 95.8) | 84.0 (68.8 to 93.9) | 0.841 | |
Subjects who showed errors in handling pMDIs | 0 (0) | 0 (0) | 0 (0) | >0.99 |
Values are presented as number (%) or median (interquartile range). We compared continuous variables between groups using the Mann-Whitney U test and analyzed categorical variables using the chi-square test or Fisher’s exact test.
PP: per protocol; FORM: formoterol fumarate dihydrate; BDP: beclomethasone dipropionate; BUD: budesonide; ACT: Asthma Control Test; ACQ: Asthma Control Questionnaire; QLQAKA: Quality of Life Questionnaire for Adult Korean Asthmatics; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 second; FEF25-75: forced expiratory flow at 25% to 75% of forced vital capacity; FeNO: fractional nitric oxide concentration in exhaled breath; pMDI: pressurized metered-dose inhaler.
Description | FORM/BDP | FORM/BUD | p-value | |
---|---|---|---|---|
Design and size | ||||
I am satisfied with the design of inhaler | 60.0 (50.0-100.0) | 50.0 (50.0-80.0) | 0.068 | |
I am satisfied with the connection (or disconnection) between cap and body | 55.0 (50.0-100.0) | 50.0 (50.0-87.5) | 0.244 | |
The inhaler is large | 50.0 (50.0-50.0) | 50.0 (50.0-50.0) | 0.498 | |
I am satisfied with the size of inhaler | 70.0 (50.0-100.0) | 56.0 (50.0-97.5) | 0.168 | |
Convenience and easiness | ||||
It is convenient to grip the inhaler | 80.0 (50.0-100.0) | 55.0 (50.0-100.0) | 0.167 | |
It is easy to press the canister of the inhaler | 65.0 (50.0-100.0) | 70.0 (50.0-100.0) | 0.883 | |
It is generally easy to use the inhaler | 95.0 (55.0-100.0) | 70.0 (50.0-100.0) | 0.123 | |
It is generally convenient to use the inhaler | 100.0 (55.0-100.0) | 70.0 (50.0-100.0) | 0.235 | |
Smell and taste | ||||
The smell of the inhaled drug is strong | 20.0 (0.0-67.5) | 0.0 (0.0-42.5) | 0.061 | |
I am satisfied with the smell of the inhaled drug | 0.0 (0.0-50.0) | 0.0 (0.0-50.0) | 0.336 | |
The taste of the inhaled drug is strong | 5.0 (0.0-65.0) | 0.0 (0.0-10.0) | 0.030* | |
I am satisfied with the taste of the inhaled drugs | 0.0 (0.0-50.0) | 0.0 (0.0-50.0) | 0.786 | |
Flume and inhaled drug | ||||
The velocity of the flume is high | 80.0 (50.0-100.0) | 50.0 (32.5-50.0) | 0.011* | |
The velocity of the flume is adequate | 92.5 (50.0-100.0) | 50.0 (32.5-77.5) | 0.013* | |
I feel the inhaled drug reach my trachea and bronchus | 87.5 (50.0-100.0) | 30.0 (0.0-50.0) | <0.001* | |
I feel the inhaled drug irritate me | 55.0 (50.0-100.0) | 12.5 (0.0-50.0) | 0.001* | |
Overall satisfaction | ||||
Overall, I am satisfied with the inhaler | 60.0 (50.0-80.0) | 50.0 (50.0-80.0) | 0.175 |
Tae-Hyun Nam
https://orcid.org/0000-0003-2552-5164
Sung-Yoon Kang
https://orcid.org/0000-0001-5505-3028
Sang Min Lee
https://orcid.org/0000-0002-9568-2096
Tae-Bum Kim
https://orcid.org/0000-0001-5663-0640
Korea Health Industry Development Institute
https://doi.org/10.13039/501100003710
Ministry of Health and Welfare
https://doi.org/10.13039/501100003625
HI19C0481
HC20C0076
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