Study in Adult Patients With Moderate to Severe Asthma (NCT04886999) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 3 trial for moderate to severe asthma that has already completed — is there published data on the results I could review with you, and what did the findings show about how patients' own perceptions of their asthma changed during the 14-day treatment period?
2Since the trial measured patient-reported perceptions of asthma using a VAS score rather than a traditional clinical outcome like lung function, what does that tell us about what this treatment is actually trying to improve — symptom experience or something measurable in the clinic?
3The treatment period in this trial was only 14 days — does that short window give us enough information to understand how a treatment like this might work for someone managing asthma long-term?
4Given that this trial focused on moderate to severe asthma specifically, how would you assess whether my current asthma severity would have matched the type of patients enrolled, and does that affect whether the results are relevant to my situation?
5Now that this trial is completed, is the treatment being studied available through standard care, another trial, or not yet accessible — and would it be worth exploring as an option compared to what I'm currently on?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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