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Tiotropium in Combination with Placebo, Salmeterol, or Fluticasone–Salmeterol for Treatment of Chronic Obstructive Pulmonary Disease
- Shawn D. Aaron, MD;
- Katherine L. Vandemheen, BScN;
- Dean Fergusson, PhD;
- François Maltais, MD;
- Jean Bourbeau, MD;
- Roger Goldstein, MD;
- Meyer Balter, MD;
- Denis O'Donnell, MD;
- Andrew McIvor, MD;
- Sat Sharma, MD;
- Graham Bishop, MD;
- John Anthony, MD;
- Robert Cowie, MD;
- Stephen Field, MD;
- Andrew Hirsch, MD;
- Paul Hernandez, MD;
- Robert Rivington, MD;
- Jeremy Road, MD;
- Victor Hoffstein, MD;
- Richard Hodder, MD;
- Darcy Marciniuk, MD;
- David McCormack, MD;
- George Fox, MD;
- Gerard Cox, MB;
- Henry B. Prins, MD;
- Gordon Ford, MD;
- Dominique Bleskie, BHScN;
- Steve Doucette, MSc;
- Irvin Mayers, MD;
- Kenneth Chapman, MD;
- Noe Zamel, MD;
- Mark FitzGerald, MD; and
- for the Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium
- From The Ottawa Health Research Institute and University of Ottawa, Ottawa, Ontario, Canada; The University of Toronto, Toronto, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Queen's University, Kingston, Ontario, Canada; Scarborough Centenary Hospital, Scarborough, Ontario, Canada; University of Western Ontario, London, Ontario, Canada; St. Lawrence Medical Clinic, Morrisburg, Ontario, Canada; University of British Columbia, Vancouver, British Columbia, Canada; Centre de Recherche, Hôpital Laval, Université Laval, Québec, Québec, Canada; McGill University, Montréal, Québec, Canada; Dalhousie University, Halifax, Nova Scotia, Canada; University of Manitoba, Winnipeg, Manitoba, Canada; University of New Brunswick, St. John, New Brunswick, Canada; University of Saskatchewan, Saskatoon, Saskatchewan, Canada; University of Calgary, Calgary, Alberta, Canada; University of Alberta, Edmonton, Alberta, Canada; Memorial University, St. John's, Newfoundland, Canada; and The Woolcock Institute of Medical Research, Sydney, Australia.
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View larger version:Figure 1. Study flow diagram.COPD = chronic obstructive pulmonary disease.
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View larger version:Figure 2. Kaplan–Meier estimates of the probability of remaining free of exacerbations, according to treatment assignment.The unadjusted hazard ratio was 1.02 (95% CI, 0.77 to 1.37) for tiotropium plus placebo versus tiotropium plus salmeterol (P = 0.87) and 0.80 (CI, 0.60 to 1.08) for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol (P = 0.15). COPD = chronic obstructive pulmonary disease.
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View larger version:Figure 3. Changes in health-related quality of life and FEV1 over 1 year.Top. Scores on the St. George's Respiratory Questionnaire (SGRQ). Lower scores indicate improvements in quality of life. P = 0.02 for tiotropium plus placebo versus tiotropium plus salmeterol at 52 weeks; P = 0.01 for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol at 52 weeks. Bottom. Mean prebronchodilator FEV1. P = 0.87 for tiotropium plus placebo versus tiotropium plus salmeterol at 52 weeks; P = 0.049 for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol at 52 weeks.
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