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Updated: Feb 27, 2026
Intratracheal Administration of Dry Powder Formulation in Mice
Published on: July 25, 2020
Fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers compared with placebo for
Background:
A novel, inhalation-driven, multidose dry powder inhaler (MDPI) has been developed, which allows for lower doses of fluticasone propionate (Fp) and Fp/salmeterol (FS) for the treatment of patients with asthma.
Objective:
This phase III, multicenter, double-blind, parallel-group study (NCT02141854) evaluated the efficacy and safety of Fp MDPI and FS MDPI versus placebo MDPI.
Methods:
Patients aged ≥12 years with persistent asthma who previously took an inhaled corticosteroid with or without a long-acting beta-agonist entered a 14- to 21-day run-in period, during which they received single-blind, low-dose Fp MDPI 50 μg (1 inhalation twice daily [b.i.d.]) and used albuterol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) for rescue. The patients who continued to meet eligibility criteria (N = 728) were randomized to Fp MDPI (100 or 200 μg), FS MDPI (100 μg/12.5 μg or 200 μg/12.5 μg), or placebo (1 inhalation b.i.d.). Primary efficacy end points were the change from baseline in forced expiratory volume in 1 second (FEV1) and the baseline-adjusted area under the FEV1 curve 12 hours after the dose at week 12. Secondary efficacy end points were A.M. peak expiratory flow, asthma symptom scores, albuterol HFA MDI use, time to patient withdrawal, Asthma Quality of Life scores, and time to 15% and 12% improvement from baseline in FEV1. Safety end points were monitored.
Results:
Fp MDPI and FS MDPI significantly improved both primary end points compared with placebo (p < 0.05). FS MDPI significantly improved both end points versus the corresponding Fp MDPI dose (p < 0.05), with improvement also greater for FS MDPI 100 μg/12.5 μg versus Fp MDPI 200 μg (p < 0.05). Both active treatments improved a variety of secondary end points and exhibited a safety profile consistent with the drug classes.
Conclusion:
Delivery of Fp and FS via the novel MDPI provided significant clinical benefits and was well tolerated in patients with persistent asthma.
Insights
A new multidose dry powder inhaler (MDPI) effectively delivered lower doses of fluticasone propionate (Fp) and Fp/salmeterol (FS) for asthma treatment. Both Fp MDPI and FS MDPI showed significant clinical benefits and were well-tolerated in patients with persistent asthma.
Area of Science:
- Respiratory Medicine
- Pharmacology
- Clinical Trials
Background:
- A novel inhalation-driven, multidose dry powder inhaler (MDPI) enables lower doses of fluticasone propionate (Fp) and Fp/salmeterol (FS).
- This technology aims to improve treatment delivery for patients with asthma.
Purpose of the Study:
- To evaluate the efficacy and safety of Fp MDPI and FS MDPI compared to placebo MDPI in persistent asthma patients.
- To assess the impact of the novel MDPI on primary and secondary efficacy endpoints and safety.
Main Methods:
- Phase III, multicenter, double-blind, parallel-group study (NCT02141854) involving 728 patients aged ≥12 years with persistent asthma.
- Randomization to Fp MDPI (100 or 200 μg), FS MDPI (100 μg/12.5 μg or 200 μg/12.5 μg), or placebo MDPI (1 inhalation twice daily) for 12 weeks.
- Primary endpoints included change in FEV1 and area under the FEV1 curve; secondary endpoints covered symptoms, quality of life, and rescue medication use.
Main Results:
- Both Fp MDPI and FS MDPI demonstrated statistically significant improvements in primary efficacy endpoints compared to placebo (p < 0.05).
- FS MDPI showed significant advantages over corresponding Fp MDPI doses, including FS MDPI 100 μg/12.5 μg versus Fp MDPI 200 μg.
- Active treatments improved secondary endpoints and exhibited safety profiles consistent with their respective drug classes.
Conclusions:
- The novel MDPI effectively delivers Fp and FS, providing significant clinical benefits for patients with persistent asthma.
- The treatment was well-tolerated, indicating a favorable safety profile for the new inhalation device and its drug formulations.
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