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Clinical Investigations: COPD |

A 6-Month, Placebo-Controlled Study Comparing Lung Function and Health Status Changes in COPD Patients Treated With Tiotropium or Salmeterol*

James F. Donohue, MD, FCCP; Jan A. van Noord, MD, PhD; Eric D. Bateman, MB, ChB, MD; Stephen J. Langley, MB, ChB, MFPM; Angela Lee, BSc(Hons), MSc; Theodore J. Witek, Jr, DrPH; Steven Kesten, MD, FCCP; Lesley Towse, BSc(Hons)
Author and Funding Information

*From the Division of Pulmonary Medicine (Dr. Donohue), University of North Carolina, Chapel Hill, NC; the Department of Respiratory Diseases (Dr. van Noord), Atrium Medical Center, Heerlen, the Netherlands; the Respiratory Clinic (Dr. Bateman), Groot Schuur Hospital, University of Cape Town, Cape Town, South Africa; the Clinical Trials Department (Dr. Langley), North West Lung Research Center, Wythenshawe Hospital, Manchester, UK; Boehringer Ingelheim Ltd. (Ms. Lee and Ms. Towse), Bracknell, Berkshire, UK; and Boehringer Ingelheim Pharmaceuticals (Drs. Witek and Kesten), Ridgefield, CT.

Correspondence to: James F. Donohue, MD, FCCP, Division of Pulmonary Medicine, University of North Carolina, 420 Burnett-Womack Building CB-7020, Chapel Hill, NC 27599-7020; e-mail: jdonohue@med.unc.edu



Chest. 2002;122(1):47-55. doi:10.1378/chest.122.1.47
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Background: Tiotropium, a once-daily anticholinergic, and salmeterol represent two inhaled, long-acting bronchodilators from different pharmacologic classes. A trial was designed to examine the efficacy and safety of both compounds with multiple outcome measures, including lung function, dyspnea, and health-related quality of life (HRQoL) in patients with COPD.

Methods: A 6-month, randomized, placebo-controlled, double-blind, double-dummy, parallel-group study of tiotropium, 18 μg once daily via dry-powder inhaler, compared with salmeterol, 50 μg bid via metered-dose inhaler, was conducted in patients with COPD. Efficacy was assessed by 12-h monitoring of spirometry, transition dyspnea index (TDI), and the St. George’s Respiratory Questionnaire (SGRQ).

Results: A total of 623 patients participated (tiotropium, n= 209; salmeterol, n = 213; and placebo, n = 201). The groups were similar in age (mean, 65 years), gender (75% men), and baseline FEV1 (mean, 1.08 ± 0.37 L; percent predicted, 40 ± 12% [± SD]). Compared with placebo treatment, the mean predose morning FEV1 following 6 months of therapy increased significantly more for the tiotropium group (0.14 L) than the salmeterol group (0.09 L; p < 0.01). The average FEV1 (0 to 12 h) for tiotropium was statistically superior to salmeterol (difference, 0.08 L; p < 0.001). Tiotropium improved TDI focal score by 1.02 U compared with placebo (p = 0.01), whereas there was no significant change in TDI focal score with salmeterol (0.24 U). Tiotropium was superior to salmeterol in improving TDI focal score (p < 0.05). At 6 months, the mean improvement in SGRQ total score vs baseline was tiotropium, − 5.14 U (p < 0.05 vs placebo); salmeterol, − 3.54 U (p = 0.4 vs placebo); and placebo, − 2.43 U. A statistically higher proportion of patients receiving tiotropium achieved at least a 4-U change in SGRQ score compared to patients receiving placebo. Both active drugs reduced the need for rescue albuterol (p < 0.0001).

Conclusions: Tiotropium once daily produces superior bronchodilation, improvements in dyspnea, and proportion of patients achieving meaningful changes in HRQoL compared to twice-daily salmeterol in patients with COPD.

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