This trial is not actively recruiting.
This trial has completed recruitment on this platform, and is no longer accepting new referrals.
The TANGO study will evaluate the efficacy and safety of a potential new treatment to help patients with uncontrolled asthma. The study is open to people diagnosed with asthma between 18 and 75 years of age.
Why is the Study Being Conducted?
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 patients with uncontrolled asthma.
Researchers want to see if CHF6001 can help reduce asthma attacks in adult participants with uncontrolled asthma. The other goal is to learn about any medical issues the participants might have after using CHF6001.
Participants will take their assigned treatment in addition to their ongoing asthma medications.
Estimated Enrollment
Approximately 464 Participants
Phase
Phase 2Eligibility Criteria
Participants must:
Inclusion Criteria
Participants must
-
Be male or female, aged ≥18 and ≤75 years old.
-
Have a documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years.
-
Be on a stable asthma therapy with medium to high dose of inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to screening.
-
Have a prebronchodilator FEV1 ≤80% of the predicted normal value.
-
Have evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5.
-
Have a history of at least 1 asthma exacerbation leading to hospitalization within the last 12 months prior to screening or 2 or more asthma exacerbations within the last 12 months prior to screening, defined as worsening of asthma symptoms that leads to any of the following:
- Outpatient treatment with Systemic Cortico Steroids (SCS)
- Emergency Room visit that resulted in the use of SCS
Participants must not:
Exclusion Criteria
Participants must not
-
Have a history of near fatal asthma or of a past hospitalization for asthma in intensive care unit.
-
Have respiratory disorders other than asthma (COPD, active tuberculosis, bronchiectasis, etc.).
-
Be current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
-
Be pregnant or breastfeeding.
-
Have a history of alcohol/drug abuse.
About the Study
TANGO is a 52-week, randomised, double blind, multicentre, 2-arm parallel group trial assessing the efficacy of CHF6001 (total daily dose 3200μg) DPI add-on to maintenance medium or high dose inhaled corticosteroids in combination with long-acting ß2-agonists in patients with uncontrolled asthma.
We would like to ask you for your help in referring any patients who may be eligible, with their permission. Please feel free to discuss any information about the TANGO study with your patient first.
What Will Happen in This Trial
In total, your patient will have 9 visits (6 on-site and 3 via video call) over a period of 56 weeks.
Travel Support
The sponsor will reimburse patients all reasonable costs they may have due to study participation (e.g. travel to the Study Centre visits).
More details about this will be explained by the trial site and included in your informed consent form.
Your patient may ask site staff about travel support and other support offered for this trial.
Study locations
Click here to see the full list of eligibility criteria
Custom footer
