CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) +1 moredrug
Likely dose
Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04886999
NCT04886999Phase 3Completed

An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms

Chiesi Farmaceutici S.p.A.·interventional·Posted May 14, 2021·Updated Mar 27, 2026

In Brief

A Phase 3 clinical trial evaluating Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) and Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) for Asthma. Completed, enrolled 78 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMay 14, 2021
Enrollment StartFeb 24, 2022
Primary CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.1 years ago

Interventions

Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A)drug

Administered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.

Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)drug

Administered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.