Pink vs. white inhaler actuators studied for asthma symptom perception in crossover trial
Photo by Joshua Hoehne / Unsplash
Key Takeaway
Note: Exploratory study on inhaler color perception; no clinical efficacy or safety results reported.
This was a phase IIIb, randomized, double-blind, crossover trial conducted across 10 active centers. It enrolled 78 adult patients with moderate to severe asthma. The study compared the same medication—beclomethasone dipropionate 100 µg/formoterol fumarate 6 µg—delivered via two different pressurized metered-dose inhalers (pMDIs) that differed only in actuator color (pink versus white). The primary outcome was the change from baseline in the average visual analog scale (VAS) score for perceptions of asthma over a 14-day treatment period. Secondary outcomes included other VAS scores for symptom perception, Asthma Quality of Life Questionnaire (AQLQ) scores, measures of psychopharmacological aspects, patient device preference, and reliever medication use. No specific results for these outcomes, including effect sizes, p-values, or absolute numbers, are reported in the provided data. Safety and tolerability data, including adverse events and discontinuations, are also not reported. Key limitations include the study's exploratory nature and the absence of a prespecified primary objective. The study was funded by Chiesi Farmaceutici S.p.A. In practice, this research investigates the potential influence of non-pharmacological device characteristics (like color) on patient perception, but it does not provide clinical efficacy or safety data to inform treatment decisions.
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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
Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma.
New Asthma Drug Cuts Attacks Without Recent Crisis
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