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

NCT06029595 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2025-12-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Johann Christian VIRCHOW, Prof · Universitätsmedizin Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-26
Primary Completion
2025-12-09
Completion
2025-12-09

Countries

  • Argentina
  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029595 on ClinicalTrials.gov