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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

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
198 Previous Clinical Trials
307,934 Total Patients Enrolled
Fernando J. MARTINEZ, Prof.Principal InvestigatorWeill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Frequently Asked Questions

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

Is this research opportunity open to enrollment at present?

"Affirmative, the clinicaltrials.gov database provides evidence that this medical study is still recruiting patients. This trial was first published on July 12th 2021 and has been amended as recently as August 31st 2023; 3980 candidates are sought from 332 different locations."

Answered by AI

Are there any additional studies that have included CHF6001 3200µg?

"CHF6001 3200µg was first studied in 2018 at Mays Cancer Center, UT Health San Antonio. Since then, 19416 trials have been executed and there are currently 7 active ones taking place predominantly out of Gradiška, Arkansas."

Answered by AI

How prevalent is the trial in this city's healthcare institutions?

"This experimental intervention is being conducted across three Chiesi Clinical Trial sites, including Gradiška (Arkansas), Mostar (California) and Sarajevo (Colorado). Additionally, it's taking place at 332 other select locations."

Answered by AI

Has CHF6001 3200µg been given the seal of approval from the FDA?

"The safety of CHF6001 3200µg has been assessed to be a three, as there is ample clinical evidence that demonstrates both efficacy and security."

Answered by AI

What is the upper limit of enrollment for this clinical experiment?

"To conduct the trial, Chiesi Farmaceutici S.p.A., has identified a requirement for 3980 qualified patients that match its inclusion criteria. The sponsor is running clinical sites in Gradiška, Arkansas and Mostar California to recruit participants from these areas."

Answered by AI

Who else is applying?

What site did they apply to?
Chiesi Clinical Trial - Site 840643
Chiesi Clinical Trial - Site 840666
Chiesi Clinical Trial - Site 840511
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Wanting to get better from my COPD.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04636814.
All > Lung Disease > Copd
~2181 spots leftby Sep 2027
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