Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study

Figures & data

Figure 1. Patient disposition. BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

Table 1. Demographics and disease characteristics at screening (ITT population).

	BDP/FF DPI (N = 251)	BDP/FF pMDI (N = 242)
Age (years), mean (SD); range	41.6 (12.0); 19–75	41.7 (11.7); 18–76
Sex, male, n (%)	98 (39.0)	90 (37.2)
Body-mass index (kg/m²), mean (SD)	24.0 (3.32)	24.3 (3.58)
Asthma medication at study entry, n (%)
ICS alone	1 (0.4)	0
ICS/LABA fixed combination	250 (99.6)	242 (100)
Smoking status, n (%)
Non-smoker	230 (91.6)	224 (92.6)
Ex-smoker	21 (8.4)	18 (7.4)
FEV1 (L), mean (SD)^a	2.80 (0.656)	2.84 (0.732)
FEV1 (% predicted), mean (SD)^a	95.1 (11.66)	96.8 (11.55)
ACQ-6 score, mean (SD)^a	0.25 (0.241)	0.25 (0.231)

^aAssessed at screening. BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler; ICS: inhaled corticosteroid; LABA: long-acting β₂-agonist; FEV₁: forced expiratory volume in 1 s; ACQ: Asthma Control Questionnaire.

Figure 2. Pre-dose morning PEF (ITT population). *p<.05 DPI vs. pMDI. Data are adjusted mean and 95% confidence interval. Entire treatment period analyzed using analysis of covariance; individual periods analyzed using mixed model for repeated measures. Mean baseline values were 383.6 and 384.1 L/min for BDP/FF DPI and pMDI, respectively. PEF: peak expiratory flow; BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

Figure 3. Pre-dose evening PEF (ITT population). *p<.05 DPI vs. pMDI. Data are adjusted mean and 95% confidence interval, analyzed using mixed model for repeated measures. Mean baseline values were 388.8 and 390.5 L/min for BDP/FF DPI and pMDI, respectively. PEF: peak expiratory flow; BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

Figure 4. Percentage of asthma control days (ITT population). Data are adjusted mean and 95% confidence interval, analyzed using mixed model for repeated measures. Mean baseline values were 75.21 and 74.80% for BDP/FF DPI and pMDI, respectively. BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

Figure 5. Pre-dose FEV₁ (ITT population). Data are adjusted mean and 95% confidence interval, analyzed using mixed model for repeated measures. Mean baseline values were 2.81 and 2.85 L for BDP/FF DPI and pMDI, respectively. FEV₁: forced expiratory volume in 1 s; BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

Table 2. Treatment-emergent adverse events and serious adverse events (safety population).

Number (%) of patients	BDP/FF DPI (N = 252)	BDP/FF pMDI (N = 242)
Adverse events	122 (48.4)	120 (49.6)
Upper respiratory tract infection	42 (16.7)	27 (11.2)
Nasopharyngitis	12 (4.8)	12 (5.0)
Asthma exacerbation	12 (4.8)	11 (4.5)
Cough	5 (2.0)	12 (5.0)
Pharyngitis	5 (2.0)	9 (3.7)
Allergic rhinitis	8 (3.2)	3 (1.2)
Treatment-related adverse events	14 (5.6)	11 (4.5)
Pharyngitis	0	3 (1.2)
Upper respiratory tract infection	2 (0.8)	0
Tremor	3 (1.2)	2 (0.8)
Severe adverse events	4 (1.6)	4 (1.7)
Asthma exacerbation	1 (0.4)	2 (0.8)
Serious adverse events	3 (1.2)	5 (2.1)
Treatment-related serious adverse events	0	0
Adverse events leading to treatment discontinuation	7 (2.8)	4 (1.7)
Adverse events leading to death	0	0

Notes. Preferred terms are listed where the occurrence is ≥3% in either treatment group for adverse events and ≥2 patients in either group for treatment-related, severe, or serious adverse events. BDP/FF: beclomethasone dipropionate/formoterol fumarate; DPI: dry-powder inhaler; pMDI: pressurized metered dose inhaler.

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