Trials / Terminated
TerminatedNCT06029595
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 517 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Experimental: CHF6001 3200 μg | 800 μg/actuation - 2 inhalations of CHF6001 800 μg twice daily (BID) total daily dose 3200 μg |
| DRUG | Placebo Comparator: CHF6001 Placebo | 2 inhalations of CHF6001 matching placebo BID |
Timeline
- Start date
- 2023-11-26
- Primary completion
- 2025-12-09
- Completion
- 2025-12-09
- First posted
- 2023-09-08
- Last updated
- 2025-12-18
Locations
187 sites across 14 countries: Argentina, Bulgaria, Czechia, Georgia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, South Africa, South Korea, Spain
Source: ClinicalTrials.gov record NCT06029595. Inclusion in this directory is not an endorsement.