Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease
(PILASTER Trial)
Recruiting in Palo Alto (17 mi)
+453 other locations
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.12345
Research Team
KF
Klaus F. Rabe, Prof.
Principal Investigator
LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY
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.
See 3 more
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.
See 9 more
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 OverviewThe 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
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Chiesi Clinical Trial - Site 840403Miami, FL
Chiesi Clinical Trial - Site 840463Orlando, FL
Chiesi Clinical Trial - Site 840483Philadelphia, PA
Chiesi Clinical Trial - Site 840478New Windsor, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Chiesi Farmaceutici S.p.A.
Lead Sponsor
Trials
206
Patients Recruited
315,000+
Founded
1935
Headquarters
Parma, Italy
Known For
Respiratory diseases
Top Products
NEXThaler, Trimbow, Curosurf, Holoclar
Findings from Research
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]
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]
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]
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]
References
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]
Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD. [2022]
Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. [2022]
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]
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]