Allergy & Immunology
PHASE3
● Phase III
Study compares pink and white asthma inhalers for how patients perceive symptoms
ClinicalTrials.gov
Published March 30, 2026
Chiesi Farmaceutici S.p.A.
This was a research study that looked at whether the color of an asthma inhaler might change how patients feel about their symptoms. The study included 78 adults who have moderate to severe asthma. All patients tried two inhalers that contained the exact same asthma medicine. The only difference was that one inhaler had a pink actuator (the part you press) and the other had a white one.
The main goal was to see if the color influenced patients' perceptions of their asthma symptoms and their burden, as well as which device they preferred. The study also looked at quality of life scores and how often patients used their rescue medication. This was an exploratory study, meaning it was designed to gather initial information rather than to prove a specific point.
It is important to know that this report does not include any of the actual results from the study. We do not know if patients noticed a difference between the pink and white inhalers, which one they preferred, or if there were any safety issues. The study was funded by the pharmaceutical company that makes the inhalers.
Readers should understand that this was an early, exploratory look at how device appearance might affect patient experience. It does not provide any information on whether one inhaler works better or is safer than the other. The findings, when they become available, will need to be considered carefully because the study's main focus was on perception, not on proving the medicine's clinical effectiveness.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3
Condition(s): Asthma
Intervention(s): Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) (DRUG), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) (DRUG)
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.
Detailed: This was a phase IIIb, exploratory, double-blind, randomised, multicentre, psychopharmacological, 2x2 cross-over study in adult subjects with moderate to severe asthma.
A total of 78 randomised subjects in 10 actives centres were involved. The study focused on the psychopharmacological aspects, particularly on the subjects' preference for the device and on the impact of the device's features on subjects' perception of asthma symptoms. Subjects were informed that the study treatments were the same medication they had received before enrolment as maintenance therapy (i.e. Foster® 100/6 µg pMDI), but with differing device characteristics.
The study lasted approximately 6 weeks for each subject and comprised four visits (Visit \[V\] 1 to V4), including:
* Two face-to-face clinic visits: V1
Primary Outcome(s): Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3
Enrollment: 78 (ACTUAL)
Lead Sponsor: Chiesi Farmaceutici S.p.A.
Start: 2022-02-24 | Primary Completion: 2023-02-01
Results posted: 2026-03-27
