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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
Must not have
Subjects with COPD emphysema or mixed phenotypes
Subjects with clinically significant cardiovascular
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have COPD, emphysema, or a combination of lung conditions.
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I have a serious heart condition.
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I have a respiratory condition that is not COPD.
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I have been diagnosed with depression, anxiety, or have had thoughts of suicide.
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I recovered from lung cancer or any cancer less than a year ago.
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I have a serious brain or nerve condition.
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I currently have asthma.
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My COPD is caused by α-1 antitrypsin deficiency.
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I have moderate to severe liver problems.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic Obstructive Airway Disease

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
202 Previous Clinical Trials
309,594 Total Patients Enrolled
Klaus F. Rabe, Prof.Principal InvestigatorLungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY
~448 spots leftby Jun 2025
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