Claus Vogelmeier, M.D., Bettina Hederer, M Click to see more .D., Thomas Glaab, M.D., Hendrik Schmidt, Ph.D., Maureen P.M.H.D., Kai M. Beeh, M.D., Klaus F. Rabe, M.D., and Leonardo M. Fabbri, M.D. For the POET-COPD Investigators: Tiotropium versus Salmeterol for preventing Exacerbations of COPD Chronic obstructive pulmonary disease is a respected reason behind disability and death worldwide.1-3 Exacerbations of COPD indicate instability or worsening of the patient’s clinical status and progression of the disease and have been associated with the development of complications, an increased risk of subsequent exacerbations, a worsening of coexisting conditions, reduced health status and exercise, deterioration of lung function, and an elevated risk of death.4-7 The prevention of exacerbations takes its major objective of treatment therefore.1,2 Comparative studies have indicated that tiotropium is normally associated with a greater decrease in the risk of exacerbations and exacerbation-related hospitalizations than is salmeterol, even though differences were not significant.13,14 These were short-term studies and weren’t designed and powered to detect a difference in the risk of exacerbations.
To ensure that all investigational sites complied with all applicable protocol and regulations requirements, an unbiased contract research corporation monitored the study. Subjects between your ages of six months and 99 years who hadn’t previously received carbamazepine and who would as a rule have received it at the time of screening had been invited to take part in the study. We excluded subjects who had a history of carbamazepine allergy, those that had undergone bone marrow transplantation, and those who were not really of Han Chinese descent. Status regarding Han Chinese descent was decided by using a multiple-choice questionnaire that asked the subjects to identify the ethnic band of their parents and grandparents.