Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy

Study Identifier:
CLI-06001AA2-01
ClinicalTrials.gov Identifier:
NCT06029595
EudraCT Identifier:
2022-502208-64-00
EU CT ID:
2022-502208-64-00
Study Contact Information:
N/A
Active, not recruiting

Study Details

Medical Condition
  • Uncontrolled Asthma
Study Drug
  • Drug: Experimental: CHF6001 3200 μg
  • Drug: Placebo Comparator: CHF6001 Placebo
Date
Nov 2023 - Mar 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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
Healthy Volunteers
No

Protocol 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 patient population. (TANGO)

Study Locations

Location
Status
Location
Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax
Santa Fe, La, Argentina
Status
N/A
Location
Site 032027- Centro de Medicina Respiratoria
Argentina, Argentina
Status
N/A
Location
Site 032025 - Sala Mignaburu
Berazategui, Argentina
Status
N/A
Location
Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Argentina
Status
N/A
Location
Site 032008 - Mautalen Salud e Investigacion
Buenos Aires, Argentina
Status
N/A
Location
Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER)
Buenos Aires, Argentina
Status
N/A
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