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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
Must not have
Subjects with active cancer or a history of lung cancer
Subjects with primary diagnosis of emphysema not related to COPD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights
Approved for 5 Other Conditions
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have or previously had lung cancer.
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My primary diagnosis is emphysema not caused by COPD.
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I currently have asthma.
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I have moderate to severe liver problems.
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I have a respiratory disorder, but it's not COPD.
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I have a serious heart condition.
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I have been diagnosed with depression, anxiety, or have had thoughts of suicide.
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I have had surgery to remove part of my lung.
Select...
My COPD is caused by α-1 antitrypsin deficiency.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.
Secondary study objectives
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 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
202 Previous Clinical Trials
309,096 Total Patients Enrolled
Fernando J. MARTINEZ, Prof.Principal InvestigatorWeill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA