Tiotropium in Combination with Placebo, Salmeterol, or Fluticasone–Salmeterol for Treatment of Chronic Obstructive Pulmonary Disease

  1. Shawn D. Aaron, MD;
  2. Katherine L. Vandemheen, BScN;
  3. Dean Fergusson, PhD;
  4. François Maltais, MD;
  5. Jean Bourbeau, MD;
  6. Roger Goldstein, MD;
  7. Meyer Balter, MD;
  8. Denis O'Donnell, MD;
  9. Andrew McIvor, MD;
  10. Sat Sharma, MD;
  11. Graham Bishop, MD;
  12. John Anthony, MD;
  13. Robert Cowie, MD;
  14. Stephen Field, MD;
  15. Andrew Hirsch, MD;
  16. Paul Hernandez, MD;
  17. Robert Rivington, MD;
  18. Jeremy Road, MD;
  19. Victor Hoffstein, MD;
  20. Richard Hodder, MD;
  21. Darcy Marciniuk, MD;
  22. David McCormack, MD;
  23. George Fox, MD;
  24. Gerard Cox, MB;
  25. Henry B. Prins, MD;
  26. Gordon Ford, MD;
  27. Dominique Bleskie, BHScN;
  28. Steve Doucette, MSc;
  29. Irvin Mayers, MD;
  30. Kenneth Chapman, MD;
  31. Noe Zamel, MD;
  32. Mark FitzGerald, MD; and
  33. for the Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium
  1. 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.
    1. Figure 1.
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        Figure 1. Study flow diagram.

        COPD = chronic obstructive pulmonary disease.

      • Figure 2.
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          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.

        • Figure 3.
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            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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