MedTrace Logo

Study in Adult Patients With Moderate to Severe Asthma

NCT04886999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Eva Topole, MD · Chiesi Farmaceutici S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886999 on ClinicalTrials.gov