Last updated 3 months ago
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
464 patients around the world
Available in Spain, Argentina
Chiesi Farmaceutici S.p.A.
19Research sites
464Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Servicio de Investigación de Patologías Alérgicas del Instituto ABC
Instituto Médico Damic S.R.L.
Clínica Mayo de UMCB SRL
Instituto del Buen Aire
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
Instituto Ave Pulmo
Centro de Investigaciones Médicas Mar del Plata SRL
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
Instituto INSARES - Mendoza
StudyTANGO
SponsorChiesi Farmaceutici S.p.A.
Conditions
Asthma
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06029595
