Primary objective
To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow (PEF) in adult asthmatic patients not adequately controlled on high doses of ICS or on medium doses of ICS plus LABA.
Secondary objective
To evaluate the effect of CHF 1535 pMDI on clinical outcome measures and other lung function parameters and to evaluate the safety and tolerability profile.
Who can participate
Age range
18 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
. Patient's written informed consent obtained prior to any study-related procedures;
. Male or female patients aged \>=18;
. Patients with persistent asthma not optimally controlled (GINA 2010 'Management Approach Based on Control') on high doses of ICS (1000-2000 μg daily dose BDP non-extrafine or equivalent) or medium doses of ICS+LABA (500-1000 μg daily dose BDP non-extrafine or equivalent plus formoterol 24 μg or salmeterol 100 μg) at a stable dose for at least 4 weeks prior to screening; Equivalence to Medium dose High dose BDP non-extrafine 500-1000 μg \> 1000-2000 μg BDP extrafine 200-400 μg \> 400-800 μg Budesonide 400-800 μg \> 800-1600 μg Ciclesonide 160-320 μg \> 320-1280 μg Fluticasone 250-500 μg \> 500-1000 μg Mometasone 400-800 μg \> 800-1200 μg
. Patients with a FEV1 \> = 40% and \< 80% of patient's predicted normal value and an absolute value of at least 0.9 L, after appropriate washout from bronchodilators at screening and at the end of the run-in period;
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 to the Average of the Entire Treatment Period Reported, in the Average Pre-dose Morning Peak Expiratory Flow (PEF)
Timeframe: Baseline and Throughout the 12-week treatment period
. Patients with a positive response to the reversibility test at screening, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this reversibility threshold was not met, the FEV1 reversibility test could be performed once before randomisation, after an appropriate wash-out from bronchodilators. Alternatively, a documented positive response to reversibility, as defined above, within the 3 months prior to the screening visit was acceptable;
. Patients with not adequately controlled asthma evidenced by:
. Presence of at least 7 available pre-dose morning PEF measurements in the run-in period;
. Patients with a cooperative attitude and ability to be trained to correctly use the pMDI and a portable electronic peak flow meter;
Exclusion criteria
. Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake;
. Seasonal (intermittent) asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser;
. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations (3 or more asthma exacerbations/year) which, in the judgement of the Investigator, could have placed the patient at undue risk;
. Hospitalisation, emergency room (ER) admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to the screening visit and during the run-in period;
. Lower respiratory tract infection in the 4 weeks before the screening visit;
. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which could have interfered with data evaluation;
. Patients who suffered from Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
. Current smokers or ex-smokers with total cumulative exposure equal or more than 5 pack-years and/or who stopped smoking one year or less prior to screening visit;