A Randomized, Single-Blind Study of Lansoprazole for the Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease in Older Patients

OBJECTIVES To investigate whether proton pump inhibitor (PPI) therapy reduces the frequency of common colds and exacerbations in patients with chronic obstructive pulmonary disease (COPD). DESIGN Twelve-month, randomized, observer-blind, controlled trial. SETTING A university hospital and three city hospitals in Miyagi prefecture in Japan. PARTICIPANTS One hundred patients with COPD (mean age +/- SD 74.9 +/- 8.2) participated. They were all ex-smokers and had received conventional therapies for COPD, including smoking cessation and bronchodilators. Patients with gastroesophageal reflux disease or gastroduodenal ulcer were excluded. INTERVENTION Patients were randomly assigned to conventional therapies (control group) or conventional therapies plus PPI (lansoprazole 15 mg/d; PPI group) and observed for 12 months. MEASUREMENTS Frequency of common colds and COPD exacerbations. RESULTS The number of exacerbations per person in a year in the PPI group was significantly lower than that in the control group (0.34 +/- 0.72 vs 1.18 +/- 1.40; P <.001). The adjusted odds ratio with logistic regression for having exacerbation (>= once/year) in the PPI group compared with the control group was 0.23 (P=.004). In contrast, there was no significant difference in the numbers of common colds per person per year between the PPI group and the control group (1.22 +/- 2.09 vs 2.04 +/- 3.07; P=.12). PPI therapy significantly reduced the risk of catching frequent common colds (>= 3 times/year), the adjusted odds ratio of which was 0.28 (P=.048). CONCLUSION In this single-blind, nonplacebo-controlled trial, lansoprazole was associated with a significant decrease in COPD exacerbations. More definitive clinical trials are warranted.