In chronic asthmatics, particularly those that can be classed under stages 3-4 of Asthma, it is often observed that symptoms persist despite ongoing therapies such as with ICS/LABA bronchodilators. GINA-2017 guidelines recommend the use of add-on tiotropium at Step-4 along with ICS/LABA bronchodilators. The novelty of this project lies in the fact that instead of stepping-up therapy with tiotropium as an add-on therapy to ICS/LABA bronchodilators in two separate inhalers, the effectiveness and safety of Formoterol, Tiotropium and Ciclesonide in a fixed-dose combination in a single inhaler is studied. The study is a Prospective, Observational study carried out in the Out - Patient Pulmonology Department of a tertiary-care hospital. The sample size is 50 and the study period is 6 months i.e. from Dec-2016 to May-2017. The plan of work included collection of subject-data in a specially designed data-collection form. Each subject was followed for a period of 6 weeks. Baseline data was collected and mean difference in FEV1 and PEFR readings from the baseline to endpoint (6 weeks for each individual patient) over a period of 6 months was obtained till the completion of sample size. Out of the 50 patients enrolled, 3 showed non-compliance and 2 showed very less improvements in the spirometric and clinical outcomes which were statistically not significant. Subjects (n=45) showed significant improvement both clinically as well as spirometrically. In spirometric assessment, FEV1 improved with a mean difference of percentage predicted of 14.48% and PEFR also improved with a mean difference of percentage predicted of 22.6% with respect to baseline which was statistically significant. In patients with poorly-controlled asthma despite the use of inhaled corticosteroids and Long-acting β2-agonists, the fixed-dose combination of Formoterol, Tiotropium and Ciclesonide in the doses of 12mcg, 18mcg and 400mcg, two puffs once daily via triple inhaler resulted in sustained improvement in the pulmonary function in patients with moderately severe persistent asthma.
EFFECTIVENESS OF FORMOTEROL, TIOTROPIUM AND CICLESONIDE COMBINATION THERAPY IN THE MANAGEMENT OF MODERATELY SEVERE PERSISTENT ASTHMA