In: COPD22 Mar 2014
Adverse events included any new or worsened condition without respect to any possible relationship to study medication. During the study, 56.8% of the subjects receiving combination therapy, 52.3% of the subjects receiving IB, and 57.4% of the subjects receiving albuterol had at least one adverse event. For all treatment groups, worsening of lower respiratory tract symptoms was the most frequently reported type of event, including those events classified as serious. These symptoms were of the kind commonly experienced by persons with COPD. Events relating to the upper respiratory tract were also common. The incidence of adverse events from all body systems was similar in all treatment groups, with no evidence of potentiation of adverse events in the combination treatment group. During the trial, 65 patients (24 receiving combination therapy, 17 receiving IB, and 24 receiving albuterol) experienced adverse events thought by the investigators to be possibly drug related. Possible drug-related nervousness was the only event with a disproportionate number of subjects in the albuterol group. None in the IB group and one in the combination therapy group experienced nervousness. Dry mouth was the most commonly reported problem noted in the two groups receiving IB. canadian health & care mall
Eight patients died during the study: three in the combination therapy group, one in the IB group, and four in the albuterol group. None of the eight deaths was thought to be related to the study drug. There were no clinically significant changes in blood or urine test results among the three treatment groups. The differences in mean changes from baseline in BP and pulse rate were not significant within each treatment group or among the three treatment groups during the 3 h they were recorded on each of the test days. ECGs showed no clinically significant differences in chronic or acute changes among the treatment groups.
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