Trial results published in a recent article indicate that patients using tiotropium in the early stages of chronic obstructive pulmonary disease (COPD) had better lung function and a slower decline in function.
The study, published in New England Journal of Medicine
), presents the findings of a phase 4 randomized controlled trial conducted in China involving patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 or 2 COPD. Patients were assigned to receive either a placebo or tiotropium, a long-acting anticholinergic bronchodilator, via an inhaler.
The primary endpoint, the 2-year change from baseline in forced expiratory volume in 1 second (FEV1
), was significantly higher in the tiotropium group than the placebo group, with a between-group difference of 157 ml indicating significantly better lung function in the tiotropium arm. Lung function as measured by both FEV1
and forced vital capacity (FVC) was also higher in the tiotropium group at each of the follow-ups prior to the 24-month endpoint.
The annual declines in FEV1
both before and after bronchodilator use were larger in the placebo group, but the between-group difference was only significant after bronchodilator use. The placebo and tiotropium groups did not differ significantly on the FVC measures.
Patients receiving tiotropium had a longer time to the first acute exacerbation of COPD and less frequent exacerbations and hospitalizations than the control group. The tiotropium group also had higher scores on quality of life tests than the placebo group at all time points except for months 1, 3, and 12. There were no significant differences in the incidence of adverse events between the 2 groups, except for oropharyngeal discomfort, which was reported by more patients in the tiotropium arm.
The researchers concluded that tiotropium was shown to be effective in improving lung function and quality of life, as well as reducing the frequency of exacerbations, among patients with GOLD stage 1 or 2 COPD.
“Whether early intervention with tiotropium alters the long-term course of COPD remains an open question,” they wrote, noting that the observed benefits may have delayed the worsening of COPD instead of preventing it.
An accompanying editorial also published in NEJM
explored the clinical implications of these findings for drug therapies in early-stage COPD. Future studies should build on the results of the current trial to provide stronger evidence for the use of pharmaceutical treatments in the early stages of COPD, the authors wrote.
“For now, the evidence supports the judicious use of treatment in patients with symptomatic early-stage COPD or in those who are recovering from an exacerbation,” they concluded.