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Tanimilast Add-On Therapy for COPD (PILLAR Trial)

Phase 3
Recruiting
Led By Fernando J. MARTINEZ, Prof.
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least, one moderate or severe COPD exacerbation in the previous year
Post-bronchodilator FEV1 <50% of the patient predicted normal value and FEV1/FVC ratio < 0.7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights

PILLAR Trial Summary

This trial will test a drug (Tanimilast) as an add-on to existing treatments to see how safe and effective it is.

Who is the study for?
This trial is for adults over 40 with COPD and chronic bronchitis who are current or former heavy smokers. They must have had at least one moderate to severe flare-up in the past year, be on stable triple therapy for COPD, and have a certain level of lung function reduction. People with neurological diseases, active cancer, recent Roflumilast use, other respiratory disorders besides COPD, significant liver issues or cardiovascular conditions can't join.Check my eligibility
What is being tested?
The study tests two doses of CHF6001 (Tanimilast) added to standard triple therapy against a placebo and an existing medication called Roflumilast (Daliresp). It aims to see if Tanimilast is effective and safe over a period of 52 weeks in improving symptoms for those with COPD and chronic bronchitis.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with similar medications such as digestive issues, headaches, potential weight loss due to appetite changes, mood alterations like depression or anxiety which were exclusion criteria indicating their possible link to treatment.

PILLAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had at least one severe COPD flare-up in the last year.
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My lung function is severely reduced, below half of what's expected.
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I am 40 or older with COPD and chronic bronchitis.
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I have been on a consistent triple therapy for at least a year.
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I have smoked at least 10 packs of cigarettes a year.

PILLAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.
Secondary outcome measures
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
+12 more

PILLAR Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CHF6001 3200µgExperimental Treatment1 Intervention
Group II: CHF6001 1600µgExperimental Treatment1 Intervention
Group III: RoflumilastActive Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
200 Previous Clinical Trials
308,560 Total Patients Enrolled
Fernando J. MARTINEZ, Prof.Principal InvestigatorWeill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA
~2126 spots leftby Sep 2027
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