A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

Study Identifier:
CLI-06001AA1-04
ClinicalTrials.gov Identifier:
NCT04636801
EudraCT Identifier:
2020-003666-40
EU CT ID:
N/A
Study Contact Information:
N/A
Active, not recruiting

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: Experimental: CHF6001 1600µg
  • Drug: Experimental: CHF6001 3200µg
  • Drug: Placebo
Date
Jul 2021 - Dec 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria:
  • Adults aged ≥ 40 years with COPD and chronic bronchitis
  • Current or ex-smokers (history ≥ 10 pack years).
  • Post-bronchodilator FEV1 \<60% of the subject predicted normal value and FEV1/FVC ratio \< 0.7.
  • At least, one moderate or severe COPD exacerbation in previous year.
  • CAT score ≥ 10
  • Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit
  • Exclusion Criteria:
  • Subjects with current asthma.
  • Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
  • Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
  • Subjects with COPD emphysema or mixed phenotypes.
  • Subjects with known respiratory disorders other than COPD.
  • Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
  • Subjects under Roflumilast treatment within 6 months before study entry.
  • Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
  • Subjects with clinically significant cardiovascular.
  • Subjects with a significant neurological disease.
  • Subjects with clinically significant laboratory abnormalities.
  • Subjects with moderate or severe hepatic impairment
Healthy Volunteers
No

Protocol Summary

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Study Locations

Location
Status
Location
Chiesi Clinical Trial - Site 840402
Sheffield, Alabama, United States, 35660-4020
Status
N/A
Location
Chiesi Clinical Trial - Site 840480
Northridge, California, United States, 91324-6200
Status
N/A
Location
Chiesi Clinical Trial - Site 840487
Cutler Bay, Florida, United States, 33189-1230
Status
N/A
Location
Chiesi Clinical Trial - Site 840404
Hollywood, Florida, United States, 33021
Status
N/A
Location
Chiesi Clinical Trial - Site 840407
Miami, Florida, United States, 33144-2100
Status
N/A
Location
Chiesi Clinical Trial - Site 840444
Miami, Florida, United States, 33144
Status
N/A
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