Tiotropium Respimat® improves physical functioning in chronic obstructive pulmonary disease

Figures & data

Table 1 Patient demographics and characteristics at baseline

Parameter	Parameter value (mean and SD unless stated)
	Treated and full analysis sets	Efficacy set
Number of patients	1280	1230
Men (n, %)	780 (60.9%)	755 (61.4%)
Age (years)	65.5 (10.6)	65.5 (10.5)
Time since initial diagnosis (years)	7.5 (7.3)	7.5 (7.3)
Smoking status (n, %)
Smokers	454 (35.5%)	435 (35.4%)
Exsmokers	616 (48.1%)	594 (48.3%)
Never-smokers	210 (16.4%)	201 (16.3%)
Pack-years (smokers)	39.9 (32.3)	39.1 (32.0)
Pack-years (exsmokers)	33.0 (18.1)	33.0 (18.2)

Notes: Treated set = patients who received at least one dose of tiotropium Respimat^®; full analysis set = patients in the treated set with a diagnosis of COPD; efficacy set = patients in the full analysis set with a PF-10 value at baseline and at week 6.

Abbreviations: SD, standard deviation; COPD, chronic obstructive pulmonary disease.

Table 2 Absolute values of standardized PF-10 score at baseline and week 6 in efficacy set (n = 1230)

	Mean PF-10 score (SD)
All patients (n = 1230)	49.0 (24.5)
Baseline	62.3 (23.5)
Week 6	13.4 (15.9)
Difference (week 6 minus baseline)	<0.001
P value for the difference*
Smokers (n = 435)
Baseline	52.4 (24.8)
Week 6	65.0 (22.9)
Difference (week 6 minus baseline)	12.7 (15.8)
P value for the difference*	<0.001
Nonsmokers (n = 795)
Baseline	47.1 (24.1)
Week 6	60.8 (23.8)
Difference (week 6 minus baseline)	13.7 (15.9)
P value for the difference*	<0.001

Note:

* Wilcoxon signed rank test.

Figure 1 Distribution of Physicians’ Global Evaluation scores for all patients in the full analysis set (n = 1280) at baseline and week 6.

Figure 2 Ratings of patient satisfaction with the inhalation device (Respimat^® Soft Mist Inhaler) at week 6; full analysis set (n = 1280).

Abbreviation: “Neither/nor”, neither satisfied nor dissatisfied.

Table 3 Number of patients in the treated set (n = 1280) reporting adverse events, by system organ class*

	Number of patients reporting events (% of treated set)
Number of patients reporting any adverse event	51 (4.0)
Respiratory, thoracic, and mediastinal disorders	17 (1.3)
Cough	10 (0.8)
Dyspnea	5 (0.4)
Throat irritation	2 (0.2)
Gastrointestinal disorders	16 (1.3)
Dry mouth	11 (0.9)
Dyspepsia	2 (0.2)
Nervous system disorders	11 (0.9)
Dizziness	5 (0.4)
Headache	5 (0.4)
Infections and infestations	9 (0.7)
Bronchitis	2 (0.2)
Infection	2 (0.2)
Infective exacerbation of COPD	2 (0.2)
Urinary tract infection	2 (0.2)
Cardiac disorders	5 (0.4)
Tachycardia	3 (0.2)
General disorders and administration site conditions	5 (0.4)
Chest discomfort	3 (0.2)
Renal and urinary disorders	3 (0.2)
Urinary retention	2 (0.2)
Neoplasms benign, malignant, and unspecified	2 (0.2)
Skin and subcutaneous tissue disorders	2 (0.2)
Vascular disorders	2 (0.2)

Notes:

* Table contains serious and nonserious adverse events. Within each system organ class, events are also listed by preferred term if reported by two or more patients.

Abbreviation: COPD, chronic obstructive pulmonary disease.