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> Record changed: 2026-10-13

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

NCT06029595

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Recruitment status

Terminated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Participants

517

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Lead sponsor

Chiesi Farmaceutici S.p.A.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Start date

2023-11-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

Number of sites

187

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Title and summary

**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)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Acronym**

TANGO

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Recruitment status**

Terminated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Reason stopped**

Strategic decision by Sponsor; not due to safety reasons

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Dates

**Completion date**

2025-12-09

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**First posted**

2023-09-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Registry last updated**

2025-12-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Primary completion date**

2025-12-09

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Start date**

2023-11-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Size and sites

**Actual participants**

517

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Participants**

517

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Number of sites**

187

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Lead sponsor**

Chiesi Farmaceutici S.p.A.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Identifiers

**Registry ID**

NCT06029595

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**ClinicalTrials.gov ID**

NCT06029595

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masking description**

Double (Participant, Investigator)

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Outcomes

### Primary outcomes

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)

### Secondary outcomes

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

75 Years

**Healthy volunteers**

No

### 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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Sites

- 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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06029595)

## Related records

### Drugs (1)

- [Iron isomaltoside 1000](https://trialight.com/data/asset/iron-isomaltoside-1000-8f78d416-6b53-49f1-8d80-ded37eeb0ccf.md)

### Lead sponsors (1)

- [Chiesi Farmaceutici S.p.A.](https://trialight.com/data/company/chiesi-farmaceutici-s-p-a-5660c527-7b1d-469a-a2db-d1ba8061415e.md)

### Conditions (1)

- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md)

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