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Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease (PILASTER Trial)

Phase 3
Recruiting
Led By Klaus F. Rabe, 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
Current or ex-smokers (history ≥ 10 pack years)
Adults aged ≥ 40 years with COPD and chronic bronchitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights

PILASTER Trial Summary

This trial will test if a medication helps and is safe for people with a certain type of lung disease.

Who is the study for?
This trial is for adults over 40 with COPD and chronic bronchitis who are current or ex-smokers. They must have had a moderate to severe flare-up in the past year, be on triple therapy for at least 3 months, and not have emphysema, asthma, significant neurological diseases, recent roflumilast treatment, serious lab abnormalities, α-1 antitrypsin deficiency-related COPD, major heart issues or liver impairment.Check my eligibility
What is being tested?
The study tests two doses of CHF6001 (Tanimilast) added to standard triple therapy against a placebo. It aims to see if Tanimilast can improve symptoms in people with COPD and chronic bronchitis over one year.See study design
What are the potential side effects?
Potential side effects of Tanimilast may include respiratory issues like coughing or wheezing; gastrointestinal problems such as nausea or diarrhea; headaches; dizziness; potential liver function changes; and possibly increased risk of infections.

PILASTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have smoked at least 10 pack-years.
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I am 40 or older with COPD and chronic bronchitis.
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My lung function is significantly reduced.
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I had at least one severe flare-up of my COPD in the last year.

PILASTER 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
Chronic Obstructive Airway Disease
Secondary outcome measures
Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.
Change from baseline in SGRQ total and domain scores at week 52.
Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores
+9 more

PILASTER Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CHF6001 3200µgExperimental Treatment1 Intervention
Group II: CHF6001 1600µgExperimental Treatment1 Intervention
Group III: CHF6001 PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
200 Previous Clinical Trials
309,105 Total Patients Enrolled
Klaus F. Rabe, Prof.Principal InvestigatorLungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY
~896 spots leftby Jun 2025
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