drugset / Trial / NCT04886999

Study in Adult Patients With Moderate to Severe Asthma

NCT04886999

Phase 3 Completed 78 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverQuadruple-blindOther

Summary

This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective. The following objectives were assessed: * Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms and burden over the first 7 days and all 14 days in each treatment period (Questions 3-6); * Change from baseline in AQLQ score after 14 days of treatment in each period; * Summary measures of psychopharmacological aspects (Questions 7-10); * Patients' preference and perception of the devices (Questions 11-16); * Change from baseline in reliever medication use over 14 days of treatment in each period (Question 2). For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.

Timeline

Start
2022-02-24
Primary completion
2023-02-01
Completion
2023-02-01

Drugs

EvaluationDrugModalityDoseRoute
Background Formoterol Other / unclassified 6 ug Inhaled
Background beclomethasone dipropionate Other / unclassified 100 ug Inhaled

Indications