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

Phase 2

Active, not recruiting

• Conditions: Uncontrolled Asthma

• Registration Number: NCT06029595
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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 patient population. (TANGO)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-08
• Study Start: 2023-11-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-03-28
• Study Completion: 2027-02-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1. Subject's written informed consent
2. Male or female subjects aged ≥18 and ≤75 years
3. A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years
4. 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
5. A prebronchodilator FEV1 ≤80% of the predicted normal value
6. Bronchodilator responsiveness after inhalation of salbutamol or equivalent
7. Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5
8. History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months
9. A cooperative attitude and ability to use inhalers and to comply with study procedures

Exclusion Criteria

1. e-Diary completion compliance <75% during run-in
2. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit
3. Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period
4. Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation
5. Asthma requiring use of biologics
6. Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma
7. Subjects with a history of lung volume resection
8. Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
9. Subjects with cancer or history of cancer
10. Subjects with cardiovascular diseases
11. Subjects with any abnormal and clinically significant 12-lead ECG
12. Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
13. Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour
14. Patients mentally or legally incapacitated or patients accommodated in an establishment
15. Subjects with liver diseases
16. Drugs with hepatoxicity potential
17. Subjects with contra-indications to IMPs:
18. Subjects with history alcohol/drug abuse
19. Subjects with major surgery in the 3 months prior to screening visit or planned during the trial
20. 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
21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants
22. Subjects receiving any therapy that could interfere with the study drugs
23. Participation in another investigational trial
24. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks
25. Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
26. For females only: pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Asthma exacerbation over 52 weeks of treatment	Over 52 weeks	Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)

Secondary Outcome Measures

Name	Time	Method
Number of asthma exacerbation and asthma worsening over 52 weeks of treatment	Up to 52 weeks	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.
ACQ-7 responders	week 4, week 26 and week 52	ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units);
Change from baseline in ACQ-7 and ACQ-6	week 4, week 26 and week 52	Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52
Change from baseline in Mini-AQLQ	week 4, week 26 and week 52	Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52
Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;	Up to 52 weeks
Change from baseline in pre-dose FEV1	week 4, week 26 and week 52	Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;
Time to first asthma exacerbation;	Up to 52 weeks	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization
Time to first asthma exacerbation or asthma worsening	Up to 52 weeks	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.
Change from baseline in pre-dose FVC	Week4, Week 52 and Week 26	Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;
Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score	Up to 52 weeks
Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.	Up to 52 weeks

Trial Locations

Locations (187)

Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax; 🇦🇷 Santa Fe, La, Argentina

Site 032027- Centro de Medicina Respiratoria; 🇦🇷 Argentina, Argentina

Site 032025 - Sala Mignaburu; 🇦🇷 Berazategui, Argentina

Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias; 🇦🇷 Buenos Aires, Argentina

Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER); 🇦🇷 Buenos Aires, Argentina

Site 032021 - Centro De Investigaciones Medicas Mar Del Plata; 🇦🇷 Buenos Aires, Argentina

Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOS; 🇦🇷 Buenos Aires, Argentina

Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban Echeverría; 🇦🇷 Buenos Aires, Argentina

Site 032030 - Instituto de Diagnostico e Investigaciones Metabolicas (IDIM); 🇦🇷 Buenos Aires, Argentina

Site 032031 - Centro de Investigaciones Metabolicas (CINME) S.A.; 🇦🇷 Buenos Aires, Argentina

Scroll for more (177 remaining)