Status:
TERMINATED
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Uncontrolled Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2025
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT06029595
Start Date
November 26 2023
End Date
December 9 2025
Last Update
December 18 2025
Active Locations (187)
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1
Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
Santa Fe, La, Argentina
2
Site 032027- Centro de Medicina Respiratoria
Argentina, Argentina
3
Site 032025 - Sala Mignaburu
Berazategui, Argentina
4
Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Argentina