A Double-Blind Crossover Study Comparing the Safety and Efficacy of Three Weeks of Flu/Sal 250/50 bid Plus Albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid Plus Albuterol/Ipratropium Bromide 2 puffs prn q4 hours in Patients with Chronic Obstructive Pulmonary Disease

Figures & data

Figure 1 Study design: Timeline of study.

Table 1 Patient baseline characteristics

Baseline Assessment	N = 20
Age (range)	71.5 (60–83)
Male	12
Current Smokers	5
Atopic	5
FEV1 (L) mean (range)	1.12 (0.56–1.67)
FEV1 (%predicted) (range)	40.6 (21–65)
FVC (L) (range)	2.1 (1.3–3.6)
FVC % predicted (range)	60.7 (42–84)
FEV1/FVC (range)	0.50 (0.30–0.72)
% Reversibility (range)	21.9 (−4.6–71.4)
No. with significant reversibility * (% of patients)	8 (42%)
Short-acting beta-agonists (rescue)	17
Short-acting anticholinergics	2
Albuterol/Ipratropium Bromide	2
Inhaled corticosteroids	2
Long-acting beta-agonists	2
Long-acting beta-agonists/Inhaled corticosteroid use	12

> 12% and greater than 200 cc.

Table 2 Spirometry after treatment trials

	Baseline	Albuterol	Albuterol/IB	p-value
Pre-am dose FEV1 (SD)	1.14 (0.38)	1.16 (0.35)	1.18 (0.44)	n.s.
Post-am dose FEV1(SD)	1.36 (0.50)	1.74 (1.98)	1.23 (0.46)	n.s.
Pre-am dose FVC	2.18 (0.58)	2.3 (0.57)	2.2 (0.61)	n.s.
Post-am dose FVC	2.59 (0.78)	2.4 (0.70)	2.3 (0.68)	n.s.
Rescue inhaler use (puffs per day) (SD)		4.1 (1.7)	3.9 (1.4)	n.s.

Figure 2 Change in am. pre-dose FEV₁ and FVC before vs after treatment: mean (± SD). No significant differences were noted between treatment groups.

Figure 3 Change in SF36 before vs after treatment mean and standard deviation. There were no significant differences with regard to any of the SF36 domains.

Table 3 Assessment of Holter monitor data: change from baseline

	Baseline	Albuterol	Albuterol/Ipratropium Bromide	p-value
Mean Heart Rate ± SD	78.2 (9.5)	77.4 (9.5)	77.6 (8.8)	n.s.
Mean Blood pressure± SD	124 (18.8)/68 ([11])	129 (19.1)/74 (14.3)	124 (13.3)/71 (9.7)	n.s.
Supraventricular ectopics (SVEs)± SD	224 (442)	278.5 (589.6)	209 (556.7)	n.s.
Sustained and non-sustained ventricular tachycardia ± SD	0 (0)	0.45 (1.4)	4.75 (21.24)	n.s

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