Overview
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
Eligibility
Inclusion Criteria:
- Subject's written informed consent
- Male or female subjects aged ≥18 and ≤75 years
- A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years
- Stable asthma therapy: a stable maintenance treatment with medium to high dose of inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to screening
- A prebronchodilator FEV1 ≤80% of the predicted normal value
- Bronchodilator responsiveness after inhalation of salbutamol or equivalent
- Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5
- History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months
- A cooperative attitude and ability to use inhalers and to comply with study procedures
Exclusion Criteria:
- e-Diary completion compliance <75% during run-in
- History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit
- Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period
- Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation
- Asthma requiring use of biologics
- Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma
- Subjects with a history of lung volume resection
- Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
- Subjects with cancer or history of cancer
- Subjects with cardiovascular diseases
- Subjects with any abnormal and clinically significant 12-lead ECG
- Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
- Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour
- Patients mentally or legally incapacitated or patients accommodated in an establishment
- Subjects with liver diseases
- Drugs with hepatoxicity potential
- Subjects with contra-indications to IMPs:
- Subjects with history alcohol/drug abuse
- Subjects with major surgery in the 3 months prior to screening visit or planned during the trial
- Subjects treated with non-potassium sparing diuretics, nonselective β-blocking drugs, quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation
- Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants
- Subjects receiving any therapy that could interfere with the study drugs
- Participation in another investigational trial
- Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks
- Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
- For females only: pregnant or lactating women