PMID- 28763243 OWN - NLM STAT- MEDLINE DCOM- 20190813 LR - 20190813 IS - 1532-4303 (Electronic) IS - 0277-0903 (Linking) VI - 55 IP - 6 DP - 2018 Jun TI - Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. PG - 640-650 LID - 10.1080/02770903.2017.1350971 [doi] AB - OBJECTIVE: To assess the efficacy and safety of fluticasone propionate (Fp) and Fp/salmeterol (FS) administered via a novel multidose dry powder inhaler (MDPI) that is easy to use correctly in asthma patients. METHODS: This phase-3, multicenter, double-blind, parallel-group study evaluated asthmatic patients (>/=12 years of age) previously treated with either low- or mid-dose inhaled corticosteroids (ICSs) or ICS/long-acting beta agonists. After a 14- to 21-day run-in, patients were randomized to Fp MDPI 50 mcg, Fp MDPI 100 mcg, FS MDPI 50/12.5 mcg, FS MDPI 100/12.5 mcg, or placebo twice daily for 12 weeks. Change from baseline in forced expiratory volume in 1 second (FEV(1); primary endpoint) was evaluated at week 12, and serial spirometry was collected at day 1 and week 12 (subset of patients). Safety was assessed by adverse events (AEs). RESULTS: The full analysis and serial spirometry subset included 640 and 312 patients, respectively. At week 12, FS MDPI significantly improved FEV(1) from baseline at each dose vs corresponding Fp MDPI doses (p < 0.05). Change from baseline in FEV(1) for active treatment groups was significantly greater vs placebo (p < 0.05). After 12 weeks, serial spirometry was significantly greater at all time points in the FS MDPI groups vs corresponding Fp MDPI groups (p < 0.05). Improvements in serial spirometry on day 1 were maintained through week 12. AEs were similar across groups. CONCLUSIONS: Pulmonary function was significantly improved with Fp MDPI and FS MDPI vs placebo and FS MDPI vs Fp MDPI. Active treatments had a safety profile comparable to placebo. FAU - Raphael, Gordon AU - Raphael G AD - a Bethesda Allergy , Asthma and Research Center , Bethesda , MD , USA. FAU - Yiu, Gloria AU - Yiu G AD - b Teva Pharmaceuticals , Frazer , PA , USA. FAU - Sakov, Anat AU - Sakov A AD - c Teva Pharmaceuticals , Netanya , Israel. FAU - Liu, Siyu AU - Liu S AD - b Teva Pharmaceuticals , Frazer , PA , USA. FAU - Caracta, Cynthia AU - Caracta C AD - b Teva Pharmaceuticals , Frazer , PA , USA. LA - eng SI - ClinicalTrials.gov/NCT02139644 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170831 PL - England TA - J Asthma JT - The Journal of asthma : official journal of the Association for the Care of Asthma JID - 8106454 RN - 0 (Bronchodilator Agents) RN - 0 (Fluticasone-Salmeterol Drug Combination) RN - CUT2W21N7U (Fluticasone) MH - Adolescent MH - Adult MH - Aged MH - Asthma/diagnosis/*drug therapy MH - Bronchodilator Agents/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug Administration Schedule MH - Dry Powder Inhalers/adverse effects/methods MH - Female MH - Fluticasone/*administration & dosage/adverse effects MH - Fluticasone-Salmeterol Drug Combination/*administration & dosage/adverse effects MH - Forced Expiratory Volume/*drug effects MH - Humans MH - Male MH - Middle Aged MH - Spirometry MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Adverse events OT - NCT02139644 OT - device OT - inhaled corticosteroids OT - long-acting beta 2 agonists OT - pulmonary function OT - tolerability EDAT- 2017/08/02 06:00 MHDA- 2019/08/14 06:00 CRDT- 2017/08/02 06:00 PHST- 2017/08/02 06:00 [pubmed] PHST- 2019/08/14 06:00 [medline] PHST- 2017/08/02 06:00 [entrez] AID - 10.1080/02770903.2017.1350971 [doi] PST - ppublish SO - J Asthma. 2018 Jun;55(6):640-650. doi: 10.1080/02770903.2017.1350971. Epub 2017 Aug 31.