Efficacy and safety of ipratropium bromide/salbutamol sulphate administered in a hydrofluoroalkane metered-dose inhaler for the treatment of COPD

Figures & data

Figure 1 Summary of patient disposition.

Abbreviations: AE, adverse event; CFC, chlorofluorocarbon; ECG, electrocardiography; HFA, hydrofluoroalkane; IB/SAL, ipratropium bromide/salbutamol sulphate; IIT, intention-to-treat; PP, per protocol; SAE, serious adverse event.

Table 1 Baseline and demographic characteristics (ITT population)

Variable	IB/SAL HFA MDI (n=141)	IB/SAL CFC MDI (n=149)
Sex
Male (%)	138 (98)	148 (99)
Female (%)	3 (2.13)	1 (0.67)
Age (years), mean (SD)	55.2 (9.9)	56.3 (9.5)
Weight (kg), mean (SD)	58.0 (11.1)	58.8 (12.1)
Height (cm), mean (SD)	163 (7)	164 (7)
Duration of COPD (years)
Mean (SD)	4.2 (3.6)	4.7 (4.1)
Most common symptoms n (%)
Breathlessness	135 (96)	141 (95)
Cough	123 (87)	130 (87)
Smoking status (cigarettes) n (%)
Former smoker	23 (16)	25 (17)
Current smoker	26 (18)	17 (11)
Smoking status (beedis) a n (%)
Former smoker	26 (18)	30 (20)
Current smoker	65 (46)	77 (52)
Spirometry*
FEV1 (L), mean (SD)	1.73 (0.55)	1.75 (0.50)
FEV1 % predicted, mean (SD)	65 (15)	65 (13)

Notes:

a Beedis are small, thin, hand-rolled cigarettes. They comprise tobacco wrapped in a tendu or temburni leaf (plants native to Asia) and may be secured with a colorful string at one or both ends.

* P>0.05 for all comparisons.

Abbreviations: FEV₁, forced expiratory volume in one second; ITT, intention-to-treat; CFC, chlorofluorocarbon; HFA, hydrofluoroalkane; IB/SAL, ipratropium/salbutamol.

Table 2 Statistical analyses for the mean change in FEV₁ at 60 minutes for IB/SAL-HFA pMDI vs IB/SAL-CFC pMDI after dosing on day 1 and day 85 (PP population)

	Treatment	N	Mean change in FEV1 (L) at 60 minutes from baseline	Mean difference (HFA vs CFC; 95% CI)
Day 1	IB/SAL-HFA	119	0.141	0.009 (−0.094, 0.112)
	IB/SAL-CFC	130	0.128
Day 85	IB/SAL-HFA	119	0.123	0.018 (−0.062, 0.099)
	IB/SAL-CFC	130	0.115

Abbreviations: CFC, chlorofluorocarbon; CI, confidence interval; FEV₁, forced expiratory volume in one second; HFA, hydrofluoroalkane; IB/SAL, ipratropium bromide/salbutamol sulphate.

Figure 2 Mean change in FEV₁ over the 85-day treatment period.

Abbreviations: CFC, chlorofluorocarbon; FEV₁, forced expiratory volume in one second; HFA, hydrofluoroalkane; IB/SAL, ipratropium bromide/salbutamol sulphate.