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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

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
198 Previous Clinical Trials
308,479 Total Patients Enrolled
Klaus F. Rabe, Prof.Principal InvestigatorLungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being sought for this medical experiment?

"Clinicialtrials.gov indicates that this clinical study is actively enrolling patients; the trial was first advertised on July 14th 2021 and recently revisited on October 2nd 2023."

Answered by AI

Could you please provide a summary of prior research examining the impacts of CHF6001 1600µg?

"At the present time, there are two clinical trials investigating CHF6001 1600µg in Phase 3. Although Haskovo, Alabama is a site of many studies for this medication, it can be obtained from 848 different locations across the world."

Answered by AI

Does the FDA recognize CHF6001 1600µg as safe for human consumption?

"CHF6001 1600µg has been assessed as a 3 on the safety scale, which is based off of its Phase 3 status and associated data indicating efficacy and multiple rounds of testing confirming safety."

Answered by AI

Are there any medical establishments in this city conducting the trial?

"This trial is enlisting patients from various sites, including Miami, Peachtree Corners and New Windsor. Additionally, it has 382 other locations across the nation. To reduce travel demands when enrolling in this study, we recommend picking a site closest to you."

Answered by AI

Does this clinical research represent a pioneering breakthrough in its field?

"Currently, 82 cities and 34 nations host 2 ongoing CHF6001 1600µg investigations. Initially commencing in 2021, the trial funded by Chiesi Farmaceutici S.p.A., encompassed 3980 participants during its Phase 3 evaluation process. Since then, 19496 trials have been conducted."

Answered by AI

What is the uppermost participant limit for this medical experiment?

"The trial sponsor, Chiesi Farmaceutici S.p.A., requires a total of 3435 eligible participants to conduct the study across two locations: 100423 - Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases in Miami, Georgia and Chiesi Clinical Trial - Site 840437 in Peachtree Corners, New york."

Answered by AI

Who else is applying?

What site did they apply to?
Chiesi Clinical Trial - Site 840480
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04636801.
All > Lung Disease > Copd
~971 spots leftby Jun 2025
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