Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease

(PILASTER Trial)

Recruiting in Palo Alto (17 mi)

+453 other locations

Overseen by Klaus F. Rabe, Prof.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Chiesi Farmaceutici S.p.A.

Must be taking: Maintenance triple therapy

Must not be taking: Roflumilast

Disqualifiers: Asthma, Cancer, Depression, Cardiovascular, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to have been on regular maintenance triple therapy for at least 12 months before joining. This suggests you should continue your current COPD medications.

How does the drug Tanimilast differ from other treatments for COPD?

Tanimilast is unique because it is an inhaled phosphodiesterase-4 inhibitor, which targets inflammation in the lungs, unlike many other COPD treatments that focus on bronchodilation (widening of the airways). This mechanism may offer additional benefits in reducing lung inflammation for COPD patients. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have smoked at least 10 pack-years.

I am 40 or older with COPD and chronic bronchitis.

Your CAT score is 10 or higher.

Exclusion Criteria

I have not had a severe COPD flare-up in the last 4 weeks.

I have not taken Roflumilast in the last 6 months.

I have COPD, emphysema, or a combination of lung conditions.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CHF6001 (Tanimilast) or placebo as an add-on to maintenance triple therapy

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CHF6001 DPI (Tanimilast) (Phosphodiesterase-4 (PDE4) Inhibitor)

Trial Overview 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.

Participant Groups

Group I: CHF6001 3200µg Experimental Treatment 1 Intervention

Group II: CHF6001 1600µg Experimental Treatment 1 Intervention

Group III: CHF6001 Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Chiesi Clinical Trial - Site 840403 Miami, FL

Chiesi Clinical Trial - Site 840463 Orlando, FL

Chiesi Clinical Trial - Site 840483 Philadelphia, PA

Chiesi Clinical Trial - Site 840478 New Windsor, NY

More Trial Locations

Who Is Running the Clinical Trial?

Chiesi Farmaceutici S.p.A. Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

A Two-Period Open-Label, Single-Dose Crossover Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Between Cimetidine and Inhaled Extrafine CHF 5993. [2018] Label="BACKGROUND AND OBJECTIVES" NlmCategory="OBJECTIVE">CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF), and the inhaled corticosteroid beclometasone dipropionate (BDP). It is in development for chronic obstructive pulmonary disease and asthma delivered via pressurised metered-dose inhaler.

2. England pubmed.ncbi.nlm.nih.gov

Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD. [2022] CHF6001 is a novel inhaled phosphodiesterase-4 inhibitor. This Phase IIa study assessed the effects of CHF6001 on markers of inflammation in induced sputum and blood in patients with chronic obstructive pulmonary disease (COPD).

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. [2022] This study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with chronic obstructive pulmonary disease (COPD).

4. England pubmed.ncbi.nlm.nih.gov

A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. [2022] Label="BACKGROUND">Long-acting muscarinic antagonist/long-acting β2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI).

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler delivered using co-suspension delivery technology in Japanese patients with moderate-to-very severe chronic obstructive pulmonary disease. [2022] Label="BACKGROUND" NlmCategory="BACKGROUND">PINNACLE-4 evaluated the efficacy and safety of the long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in patients from Asia, Europe, and the USA with moderate-to-very severe chronic obstructive pulmonary disease (COPD). This pre-specified analysis included Japanese patients in PINNACLE-4.