Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease (PILASTER Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Chiesi Farmaceutici S.p.A.
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.
Is Tanimilast a promising drug for COPD?Yes, Tanimilast, also known as CHF6001, is a promising drug for COPD. It has shown positive effects on reducing inflammation, which is important for managing COPD symptoms.126711
What safety data is available for Tanimilast (CHF6001 DPI) in COPD treatment?The provided research does not contain safety data for Tanimilast (CHF6001 DPI) in COPD treatment. It focuses on the safety and efficacy of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) and budesonide/glycopyrrolate/formoterol fumarate (BGF MDI) in COPD patients.25789
What data supports the idea that Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease is an effective treatment?The available research does not provide specific data on Tanimilast Add-On Therapy for Chronic Obstructive Pulmonary Disease. Instead, it focuses on other treatments like glycopyrrolate/formoterol fumarate combinations, which are shown to be effective for managing the condition. Without direct data on Tanimilast, we cannot conclude its effectiveness compared to these alternatives.234710
Do I have to stop taking my current medications for this trial?The trial requires participants to continue their current maintenance triple therapy for COPD. There is no mention of stopping other medications, so the protocol does not specify any changes to other medications.
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.
My lung function is significantly reduced.
I had at least one severe flare-up of my COPD in the last year.
Exclusion Criteria
I have COPD, emphysema, or a combination of lung conditions.
I have a serious heart condition.
I have a respiratory condition that is not COPD.
I have been diagnosed with depression, anxiety, or have had thoughts of suicide.
I recovered from lung cancer or any cancer less than a year ago.
I have a serious brain or nerve condition.
I currently have asthma.
My COPD is caused by α-1 antitrypsin deficiency.
I have moderate to severe liver problems.
Treatment Details
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.
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
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]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.
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).
Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis. [2023]To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations.
Safety and pharmacokinetics of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) in healthy adult subjects of Japanese descent. [2022]BGF MDI, a budesonide, glycopyrronium, and formoterol fumarate dihydrate triple fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology, is currently in Phase III global development for chronic obstructive pulmonary disease.
Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA. [2022]COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.
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).
Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. [2021]Label="Background">Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) is a long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination therapy delivered by MDI, formulated using innovative co-suspension delivery technology. The PINNACLE-4 study evaluated the efficacy and safety of GFF MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) from Asia, Europe, and the USA. This article presents the results from the China subpopulation of PINNACLE-4.
Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. [2020]Label="PURPOSE">The triple combination therapy budesonide/glycopyrrolate/formoterol fumarate in a metered dose inhaler (BGF MDI), formulated by using innovative co-suspension delivery technology, is a new inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination for the maintenance treatment of COPD. For some patients, the use of an MDI may be optimized with a spacer. This Phase I study assessed the effect of a spacer on lung exposure, total systemic exposure, and safety of BGF MDI 320/36/9.6 μg in healthy subjects.
Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. [2021]The Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4.
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.
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).