Trial results on novel multi-dose powder inhaler were revealed at AAAAI 2017.
A novel multi-dose powder inhaler (MDPI) containing two medications can significantly help patients with persistent asthma, according to a presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI 2017) in Atlanta, Georgia.
In a phase 3 double-blind trial, researchers examined the MDPI, which includes fluticasone propionate (FP)—a steroid and decongestant used for pain, itching, and swelling from skin diseases—and fluticasone propionate/salmeterol (FS)—used to prevent symptoms of asthma and chronic obstructive pulmonary disease (COPD). Gordon Raphael, MD, of Bethesda Allergy, Asthma and Research Center in Maryland, and colleagues conducted the research, which was funded by Teva Pharmaceuticals.
The study cohort included 640 patients with asthma ages 12 and older using either inhaled corticosteroids (ICS) or ICS/long-acting beta-agonists.
“After a 14- to 21- day run-in during which patients received albuterol metered-dose inhaler for rescue, beclomethasone dipropionate metered-dose inhaler, 40 mcg twice daily (BID), and placebo MDPI BID, patients randomly received Fp MDPI 50 mcg, Fp MDPI 100 mcg, FS MDPI 50/12.5 mcg, FS MDPI 100/12.5 mcg, or placebo BID for 12 weeks,” the authors explained.
Patients reported asthma symptoms, use of the rescue medication, and, for those ages 18 years and older, Asthma Quality of Life Questionnaire (AQLQ).
Over 12 weeks, the results showed that all active treatments significantly improved asthma symptom scores (p<0.05) compared to placebo. In addition, all of the active treatments significantly reduced use of rescue medication (p<0.05). Participants in the active treatment groups also experienced AQLQ improvements from baseline to 12 weeks (p<0.05).
“Comparisons between Fp MDPI and FS MDPI were not significant for any assessed outcome except AQLQ for Fp MDPI 100 mcg versus FS MDPI 100/12.5 mcg (P<0.05),” the report continued.
All of the groups had similar adverse events.
The researchers concluded that low- and mid-dose FP MDPI and FS MDPI improved not only clinical outcomes, but quality of life as well.
The study, “Patient-Reported Outcomes and Quality of Life Improved with Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhalers Versus Placebo in Patients with Persistent Asthma,” was published in The Journal of Allergy and Clinical Immunology.