Tiotropium, formoterol, ciclesonide triple combination improves lung function and symptoms of COPD
Triple combination of tiotropium, formoterol, and ciclesonide (TFC) once daily improved lung function and symptoms in patients with chronic obstructive pulmonary disease (COPD) regardless of their smoking history, with nonsmokers deriving a greater benefit, according to a study presented at the 21st Congress of the Asian Pacific Society of Respirology (APSR 2016) held in Bangkok, Thailand.
The prospective, open-label, multicentre, real world observational study analysed 267 patients (mean age 61.4 years) with COPD who were triple therapy naïve and were in need of step-up to triple therapy as assessed by physicians. They received TFC (18/12/400 µg) once daily delivered through a single metered-dose or dry powder inhaler. [APSR 2016, abstract P141]
“A combination product containing three drugs in a single inhaler has potential to offer all the clinical benefits of the three drugs and eases the inconvenience of taking three inhalers separately,” said the researchers.
Compared with baseline, mean prebronchodilator forced expiratory volume in 1 second (FEV1) was significantly improved by 0.58 L (p<0.0001) with TFC treatment in all patients at week 24. The improvement was greater in nonsmokers compared with smokers (0.99 vs 0.2 L; p<0.0001).
Mean prebronchodilator forced vital capacity (FVC) also increased in all patients at week 24 compared with baseline (0.56 L; p<0.0001), with nonsmokers deriving a greater improvement than smokers (1.01 vs 0.15 L; p<0.0001).
Postbronchodilator FEV1 and FVC were similarly improved with TFC treatment at week 24 (p<0.0001 for all).
Additionally, COPD symptoms, as measured by COPD assessment test (CAT), were reduced at week 24 from baseline (-6.6; p<0.0001) and again, nonsmokers saw a greater improvement than smokers (-8.05 vs -5.17; p<0.0001).
“The most important risk factor for COPD is smoking, however, a significant proportion of people may develop COPD due to other factors,” said the researchers, noting that 25–45 percent of COPD patients were never-smokers.
The most common adverse events with TFC treatment were fever (n=19) and cough (n=18). Five serious adverse events leading to death occurred during the study, which the investigators considered unlikely to be related to TFC.