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

NCT06029595
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Phase
Phase 2
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Recruitment status
Terminated
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Participants
517
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Lead sponsor
Chiesi Farmaceutici S.p.A.
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Start date
2023-11-26
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Number of sites
187
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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)
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Acronym
TANGO
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Short title
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
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Official title
A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 2
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Study type
Interventional
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Reason stopped
Strategic decision by Sponsor; not due to safety reasons
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Completion date
2025-12-09
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First posted
2023-09-08
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Registry last updated
2025-12-18
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Primary completion date
2025-12-09
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Start date
2023-11-26
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Actual participants
517
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Participants
517
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
187
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Chiesi Farmaceutici S.p.A.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06029595
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06029595
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
Double (Participant, Investigator)
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Asthma exacerbation over 52 weeks of treatment

    Timeframe: 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)

  1. Time to first asthma exacerbation;

    Timeframe: 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

  2. Number of asthma exacerbation and asthma worsening over 52 weeks of treatment

    Timeframe: 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.

  3. Time to first asthma exacerbation or asthma worsening

    Timeframe: 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.

  4. ACQ-7 responders

    Timeframe: 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);

  5. Change from baseline in ACQ-7 and ACQ-6

    Timeframe: week 4, week 26 and week 52

    Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52

  6. Change from baseline in Mini-AQLQ

    Timeframe: week 4, week 26 and week 52

    Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52

  7. Change from baseline in pre-dose FEV1

    Timeframe: week 4, week 26 and week 52

    Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;

  8. Change from baseline in pre-dose FVC

    Timeframe: Week4, Week 52 and Week 26

    Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;

  9. Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;

    Timeframe: Up to 52 weeks

  10. 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

    Timeframe: Up to 52 weeks

  11. 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.

    Timeframe: Up to 52 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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

  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
Sources for eligibility
clinicaltrials.gov

  • Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del ToraxSanta Fe, Argentina
  • Site 032027- Centro de Medicina RespiratoriaArgentina, Argentina
  • Site 032025 - Sala MignaburuBerazategui, Argentina
  • Site 032004 - CARE - Centro de Alergia y Enfermedades RespiratoriasBuenos Aires, Argentina
  • Site 032008 - Mautalen Salud e InvestigacionBuenos Aires, Argentina
  • Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER)Buenos Aires, Argentina
  • Site 032021 - Centro De Investigaciones Medicas Mar Del PlataBuenos Aires, Argentina
  • Site 032024 -CEMLO- Consultorio Medico CEMLO LOBOSBuenos Aires, Argentina
  • Site 032029 - Hospital de Alta Complejidad del Bicentenario de Esteban EcheverríaBuenos 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
  • Site 032032 - Hospital Italiano de Buenos Aires (HIBA)Buenos Aires, Argentina
  • Site 032003 -Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.LCiudad de Buenos Aires, Argentina
  • Site 032026 - IAAER-Instituto de Asma, Alergia y Enfermedades RespiratoriasCorrientes, Argentina
  • Site 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMICCórdoba, Argentina
  • Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIRLa Plata, Argentina
  • Site 032013 - Centro de Investigacion Medico Lanus-CIMEL CHAHIN CHAHIN S.ALanus, Argentina
  • Site 032006 -Institute Fundacion Enfisema - Instituto Ave Pulmo; Hospital Privado de Comunidad (HPC)Mar del Plata, Argentina
  • Mendoza, Argentina
  • Site 032009 - Centro Medico INSARESMendoza, Argentina
  • Site 032023 - Respira Salud Clinica IntegralMendoza, Argentina
  • Site 032011 - Centro Privado de Medicina Respiratoria de Parana - CPMRParaná, Argentina
  • Site 032007 - Instituto Especialidades de la Salud Rosario - Clinica del ToraxRosario, Argentina
  • Site 032016 - Instituto Medico de la Fundacion Estudios ClinicosRosario, Argentina
  • Site 032019 - Servicio de Investigacion de Patologias Alergicas del Instituto ABC - RosarioRosario, Argentina

And 162 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)