A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

Study Identifier:
CLI-06001AA1-05
ClinicalTrials.gov Identifier:
NCT04636814
EudraCT Identifier:
2020-003648-97
EU CT ID:
N/A
Study Contact Information:
N/A
Active, not recruiting

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: CHF6001 1600µg
  • Drug: CHF6001 3200µg
  • Drug: Placebo
  • Drug: Roflumilast
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 with chronic bronchitis.
  • Current smokers or ex-smokers (history of ≥10 pack years).
  • Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
  • At least, one moderate or severe COPD exacerbation in the 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 before study entry and randomisation
  • Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
  • Subjects with primary diagnosis of emphysema not related to COPD.
  • Subjects with known respiratory disorders other than COPD.
  • Subjects with lung volume reduction surgery.
  • Subjects with active cancer or a history of lung cancer.
  • 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 condition.
  • Subjects with neurological disease.
  • Subjects with clinically significant laboratory abnormalities.
  • Subjects with moderate or severe hepatic impairment.
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to evaluate the efficacy and the 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 840635
Andalusia, Alabama, United States, 36420-5310
Status
N/A
Location
Chiesi Clinical Trial - Site 840614
Foley, Alabama, United States, 36535-2248
Status
N/A
Location
Chiesi Clinical Trial - Site 840670
Guntersville, Alabama, United States, 35976-2206
Status
N/A
Location
Chiesi Clinical Trial - Site 840720
Mobile, Alabama, United States, 36608
Status
N/A
Location
Chiesi Clinical Trial - Site 840643
Saraland, Alabama, United States, 36571-3014
Status
N/A
Location
Chiesi Clinical Trial - Site 840638
Phoenix, Arizona, United States, 85018-5434
Status
N/A
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