CompletedPhase 3

Study in Adult Patients With Moderate to Severe Asthma

Italy78 participantsStarted 2022-02-24

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject's and/or subject legal representative's written informed consent obtained prior to any study related procedure. * Age: ≥18 and ≤75 years of age. * Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit * Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit * Asthma Control Test (ACT) ≥ 20 at screening/randomisation visit. * Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS) * Subject willing and able to download the application on their personal electronic device to fill in the study e-diary. * Female subject of non-childbearing potential defined as physiologically incapable of becoming pregnant or female subject + male Partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4 Exclusion Criteria: * Pregnant or lactating woman * History of 'at risk' asthma * Recent exacerbation * Non-permanent asthma * Asthma requiring more than 1 inhaler for maintenance treatment and more than 1 inhaler for reliever treatment. * Asthma requiring use of biologics * Respiratory disorders * Lower tract respiratory infection * Current smoker or ex-smoker with a smoking current use/history of ≥ 10 pack-years * Cardiovascular diseases * Subject with historical or current eviden…

What they're measuring

Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3

Timeframe: Baseline and Treatment Day 14 within each treatment period

Trial details

NCT IDNCT04886999

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-01

Results submitted2026-01-21