Asthma
Conditions
Brief summary
The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma
Detailed description
Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe controlled asthma adult subjects will be recruited. A total of 513 subjects will be randomised. The whole study will last approximately 16 weeks for each subject.
Interventions
DRUGCHF5993 200/6/12.5 μg pMDI HFA-152a
Pressurised Metered Dose Inhaler-2 inhalations twice daily
DRUGInhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
Pressurised Metered Dose Inhaler-2 inhalations twice daily
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
Intervention model description
Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject's written informed consent obtained prior to any study related procedure; * Male and female adults aged ≥ 18 and ≤ 75; * Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive; * Non-smokers or ex-smokers who smoked \< 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking \> 1 year (6 months for e-cigarettes) prior to screening; * Diagnosis of asthma: physician-diagnosed asthma for at least * 6 months and with diagnosis before the age of 50 years; * Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine \> 500-1000 μg and \> 1000 μg respectively, or estimated clinical comparable dose). * Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.
Exclusion criteria
* History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment; * Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation); * Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) | Day 1 | Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) | Day 1, Day 7, Week 4, Week 12 | Relative change from pre-dose in FEV1 at all the post dose timepoints |
| To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) | Day 1, Day 7, Week 4, Week 12 | Absolute change from pre-dose in FEV1 at all post-dose timepoints |
| To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1) | Day 1, Day 7, Week 4, Week 12 | Calculation of number and percentage of subjects with a relative decrease from pre-dose in FEV1 at each post-dose timpoint and at any post -dose timepoint \> 15% |
| To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1) | Day 1, Day 7, Week 4, Week 12 | Absolute and relative changes from baseline in pre-dose FEV1 at all clinical visits |
| To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) | Day 1, Day 7, Week 12 | Change from pre-dose in FEV1 AUC 0-2h |
| Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period | Inter-visit, over the entire 12 weeks treatment period | Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF |
| Percentage of days without intake of rescue medication. | Inter-visit, over the entire 12 weeks treatment period | Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medications |
| Change in the average daily use of rescue medication. | Inter-visit, over the entire 12 weeks treatment period | Change from baseline at each inter-visit period and over the entire treatment period in the average daily use of rescue medication (number of inhalations/day) |
| Change on the average daily asthma symptoms. | Inter-visit, over the entire 12 weeks treatment period | Change from baseline at each inter-visit period and over the entire treatment period in the average daily symptoms. Patients are asked to complete daily a questionnaire to collect this information and allow their asthma symptoms to be monitored. |
| Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. | At each planned on site study visit, during the entire 12 weeks treatment period. | ACQ 7 is a one week recall questionnaire including 6 questions to be completed by patients on a 7-points scale (0=no impairment, 6= maximum impairment) and 7th point capturing the FEV1 % predicted value (also scoring on a 7-point scale). Questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). |
Countries
Bulgaria, Czechia, Georgia, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDave Singh, MD
Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital
Outcome results
None listed