Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease

(PILASTER Trial)

Not currently recruiting at 559 trial locations

Overseen By Chiesi Clinical Trial info

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new drug, Tanimilast, works when added to current treatments for people with Chronic Obstructive Pulmonary Disease (COPD). Researchers aim to determine if Tanimilast can improve breathing and overall health for those experiencing frequent flare-ups. Participants will receive either one of two doses of Tanimilast or a placebo. The trial seeks individuals who have had COPD with chronic bronchitis for at least a year, are current or former smokers, and have experienced a significant COPD flare-up in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CHF6001, also known as Tanimilast, is generally well-tolerated. In one study examining its safety alongside other treatments, participants reported mostly mild to moderate side effects, similar to those seen with comparable treatments.

Tanimilast is an inhaled medication that reduces lung swelling, improving breathing for individuals with conditions like Chronic Obstructive Pulmonary Disease (COPD). Previous research suggests that this treatment does not cause serious side effects, making it a relatively safe option for patients.

However, all treatments can have side effects, which may vary from person to person. Prospective clinical trial participants should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Unlike the standard treatments for Chronic Obstructive Pulmonary Disease (COPD), which typically include bronchodilators and inhaled corticosteroids, Tanimilast offers a fresh approach. This drug is a phosphodiesterase 4 (PDE4) inhibitor, which means it works by reducing inflammation in the airways in a unique way compared to other medications. Researchers are particularly excited about Tanimilast because it can be delivered directly to the lungs through a dry powder inhaler, potentially improving its effectiveness and minimizing side effects. Plus, having different dosage options like the 1600µg and 3200µg makes it adaptable to individual patient needs.

What evidence suggests that Tanimilast could be an effective treatment for COPD?

Research has shown that tanimilast, an inhaled medication, may help treat chronic obstructive pulmonary disease (COPD) by reducing lung inflammation, a major issue in COPD. In animal studies, tanimilast proved effective and well-tolerated, suggesting potential improvements in lung function. Lab tests on human tissue also confirmed its ability to reduce inflammation in COPD. These findings suggest that tanimilast could help manage COPD symptoms when used alongside current treatments. Participants in this trial will receive either CHF6001 at 1600µg, CHF6001 at 3200µg, or a placebo to evaluate its effectiveness and safety as an add-on therapy for COPD. ^{3 4 6 7 8}

Who Is on the Research Team?

Klaus F. Rabe, Prof.

Principal Investigator

LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CHF6001 DPI (Tanimilast)

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.

How Is the Trial Designed?

Group I: CHF6001 3200µg Experimental Treatment 1 Intervention

Group II: CHF6001 1600µg Experimental Treatment 1 Intervention

Group III: CHF6001 Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Chiesi Farmaceutici S.p.A.

Lead Sponsor

Trials

206

Recruited

315,000+

Founded

1935

Headquarters

Parma, Italy

Known For

Respiratory diseases

Top Products

NEXThaler, Trimbow, Curosurf, Holoclar

Published Research Related to This Trial

In a study of 1130 patients with chronic obstructive pulmonary disease (COPD), the novel inhaled phosphodiesterase-4 inhibitor CHF6001 did not show significant improvements in lung function (pre-dose FEV1) compared to placebo after 12 weeks, indicating limited efficacy in this primary outcome.

However, CHF6001 was well tolerated with no significant safety concerns, and post-hoc analyses suggested that patients with chronic bronchitis, especially those with higher eosinophil counts, may benefit more from the treatment, showing significant reductions in exacerbation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. Singh, D., Emirova, A., Francisco, C., et al.[2022]

In a study involving 26 participants, the combination of CHF 5993 (a triple therapy for COPD and asthma) and cimetidine showed small but statistically significant increases in the plasma levels of glycopyrronium bromide (GB), indicating that cimetidine slightly enhances the drug's absorption without causing major changes in its elimination.

The study found no clinically relevant drug-drug interactions between CHF 5993 and cimetidine, as there were few adverse events reported and no serious adverse events, suggesting that the combination is safe for patients.

NCBI (Pubmed)

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. Mariotti, F., Ciurlia, G., Spaccapelo, L., et al.[2018]

In a Phase IIa study involving 61 patients with COPD, CHF6001, an inhaled phosphodiesterase-4 inhibitor, demonstrated significant anti-inflammatory effects, particularly reducing key inflammatory markers in sputum and blood compared to placebo.

Specifically, CHF6001 at a dose of 800 μg significantly decreased macrophage counts and various inflammatory mediators, including TNFα, indicating its potential to enhance treatment outcomes for patients already on triple inhaled therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD. Singh, D., Beeh, KM., Colgan, B., et al.[2022]

In a study involving 150 Japanese patients with moderate-to-very severe COPD, the fixed-dose combination of glycopyrrolate/formoterol fumarate (GFF MDI) significantly improved lung function compared to both its individual components and placebo, with a notable increase in forced expiratory volume (FEV1).

The GFF MDI also showed positive trends in patient-reported outcomes related to dyspnea and quality of life, while treatment-related adverse events were low, occurring in 4.5% or fewer patients, indicating a favorable safety profile.

NCBI (Pubmed)

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. Gon, Y., Nishi, K., Sato, K., et al.[2022]

The fixed-dose combination of glycopyrrolate and formoterol (GFF MDI) significantly improved lung function in patients with moderate-to-very severe COPD after 7 days of treatment, outperforming monocomponent inhalers and placebo.

Both doses of GFF MDI (72/9.6 μg and 36/9.6 μg) were well tolerated, indicating a favorable safety profile for this combination therapy in managing COPD.

NCBI (Pubmed)

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. Reisner, C., Fabbri, LM., Kerwin, EM., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8650159/

Tanimilast, A Novel Inhaled Pde4 Inhibitor for the Treatment of ... In summary, tanimilast was effective and well tolerated upon topical administration in pulmonary inflammation animal models relevant to COPD and asthma.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04636801

NCT04636801 | A 52-week, Placebo-controlled Study to ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7510119/

Efficacy and safety of CHF6001, a novel inhaled PDE4 ... This study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with ...

4. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A4632

Ex-vivo Efficacy of Tanimilast in Human COPD-derived ... CONCLUSION: The obtained results confirm the anti-inflammatory effect of tanimilast in the context of COPD and underline its ability to affect mucus ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0090955624148490

Pharmacokinetics and absorption, distribution, metabolism ... This trial investigates pharmacokinetic and absorption, distribution, metabolism and excretion profile of tanimilast, an inhaled phosphodiesterase-4 inhibitor.

6. go.drugbank.com go.drugbank.com/drugs/DB12800/clinical_trials?conditions=DBCOND0031289&phase=1&purpose=other&status=completed

CHF-6001 Completed Phase 1 Trials for Chronic ... Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and ...

7. chiesi.com chiesi.com/en/tanimilast-phase-3-pilaster-study-copd-results/

Results of the Tanimilast Chiesi Group today announced the results of the tanimilast Phase III PILASTER clinical study in Chronic obstructive pulmonary disease (COPD).

8. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-020-01512-y

Efficacy and safety of CHF6001, a novel inhaled PDE4 ... This study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with ...