Mometasone furoate (MF) delivered by the Breezhaler® device was found to be noninferior to MF delivered by the Twisthaler® at corresponding inhaled corticosteroid (ICS) doses in patients with asthma, according to study results published in Pulmonary Pharmacology and Therapeutics.
In this randomized, double-blind study, 739 adolescents and adults with persistent asthma were enrolled. Study participants were on ICS therapy up to the maximum per-day dose, and had been on a stable regimen for ≥4 weeks before study start. In addition, patients were eligible if they had a predefined lung function and worsening of 1 asthma symptom upon ICS withdrawal or dose reduction during the run-in period.
Patients were randomly assigned to receive Breezhaler-delivered MF at 80 μg (n=188) or 320 μg (n=184), or Twisthaler-delivered MF at 200 μg (n=181) or 800 μg (n=186), all once-daily and with added placebo. All participants received an inhaled short-acting β2-agonist as rescue therapy. The trough forced expiratory volume in 1 second (FEV1) at day 29 was the study’s primary end point.
After 4 weeks of treatment, the least squares (LS) mean difference in trough FEV1 between Breezhaler-delivered MF low dose 80 μg and Twisthaler-delivered MF low dose 200 μg was 27 mL (95% CI, -34 to 89). The LS mean difference in trough FEV1 between MF high dose (Breezhaler) and MF high dose (Twisthaler) was 0 mL (95% CI, -60 to 61).
No significant or clinical differences were observed between the treatment regimens. In addition, clinically relevant improvements were observed in all treatment groups after 4 weeks of treatment, as indicated by response to the Asthma Control Questionnaire-5. No difference was found between treatments in terms of safety. During the 4-week study period, all participants had a decrease in the mean daily number of puffs of rescue medication when compared with baseline.
A limitation of this study was the inclusion of patients sensitive to ICS, which may have reduced the generalizability of the findings.
“Inhaled MF is an efficacious treatment option for patients with asthma with a favorable safety profile,” the study authors concluded.
Disclosure: This clinical trial was supported by Novartis. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Buhl R, Tanase AM, Hosoe M, et al. A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma [published online May 7, 2020]. Pulm Pharmacol Ther. doi:10.1016/j.pupt.2020.101919