A Single-centre, Single-dose, Open Label, Non-randomized, Parallel Group, Clinical Pharmacology Study of CHF 6001 in Asthmatic Adolescent Patients and in Asthmatic Adult Patients as Control Group

The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.

Start Date28 Mar 2025

Sponsor / Collaborator

CHIESI Farmaceutici SpA

NCT06892756

/ CompletedPhase 1

Open-label, Non-randomised, Single-dose, One Sequence, Two-period, Cross-over Study to Investigate the Effect of Inhibition of P-glycoprotein and Breast Cancer Resistance Protein Transporters by Cyclosporine on the Pharmacokinetics of CHF6001 in Healthy Volunteers

The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein [P-gp] and breast cancer resistance protein [BCRP] transporters) on CHF6001 (Tanimilast) systemic exposure following single dose administration, by comparing the area under the curve (AUC) from time 0 to the last quantifiable concentration (AUC0 t) and the maximum plasma concentration (Cmax) of CHF6001 with and without cyclosporine. Participants will receive CHF6001 alone in Treatment Period 1, then CHF6001 after oral cyclosporine in Treatment Period 2, in order to evaluate the cyclosporine drug interaction on CHF6001 systemic exposure. The two treatment periods will be separated by a wash out period of 14 to 17 days.

Start Date18 Mar 2025

Sponsor / Collaborator

CHIESI Farmaceutici SpA

100 Clinical Results associated with Tanimilast

100 Translational Medicine associated with Tanimilast

100 Patents (Medical) associated with Tanimilast

Literatures (Medical) associated with Tanimilast

01 Oct 2025·RESPIRATORY MEDICINE

Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler® and asthma control among adult asthmatic patients in Europe: The results of the Newton study

Article

Author: Corsico, Angelo Guido ; Gálffy, Gabriella ; Lagrange, Olivier ; Braido, Fulvio ; Gómez-Bastero Fernández, Ana ; Arcoleo, Giuseppe ; Sabato, Eugenio ; Sauvage, Maxime ; Castellani, Walter ; Sárközi, Anna ; Maurer, Cyril ; Mucsi, János ; Franz, Karl-Heinz ; Álvarez Gutiérrez, Francisco Javier ; Jäger, Anca-Georgia ; Caruso, Cristiano ; Todea, Doina Adina ; Trofor, Antigona ; Nava, Stefano ; Beeh, Kai-Michael ; Xanthopoulos, Athanasios ; Tamási, Lilla ; Venturi, Barbara Canari ; Gerhard Ingerl, Hermann Harald ; Cannata, Enzo Vincenzo ; Baglioni, Stefano ; Serrano, Carolina Cisneros ; Dinh-Xuan, Anh Tuan ; Rivera, Carlos Martínez ; Piraino, Alessio ; Fira-Mlădinescu, Ovidiu ; Morlino, Paride ; Fourar-Laidi, Naim ; Michieletto, Lucio ; Calabrese, Cecilia ; Ingrassia, Eleonora ; Laßmann, Hendrik ; Ricci, Alberto ; Schultz, Thomas ; Senna, Gianenrico ; Pennisi, Alfio ; Toma, Claudia Lucia ; Rial Prado, Manuel Jorge ; Brussino, Luisa ; Askar, Bader ; Pegliasco, Herve ; Santus, Pierachille ; Gracia, Ibon Eguíluz ; Ponticiello, Antonio

PURPOSE:

The NEWTON study aims to describe clinical characteristics and evolution of asthma control of adult asthmatic patients treated with extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg.

SUBJECTS AND METHODS:

NEWTON (NCT05168995) is a European multinational, multicentre, observational, prospective cohort study that included adults with uncontrolled or poorly controlled asthma, starting BDP/FF NEXThaler® 100/6 μg treatment within 14 days of enrolment and with no use of extrafine formulations in the previous 6 months. Improvement of asthma control, lung function, quality of life (QoL), treatment adherence, and satisfaction with the device were assessed after 3 and 6 months from the enrolment visit. In addition, safety events were monitored.

RESULTS:

620 subjects were enrolled in the study. 423 completed the ACQ-5 questionnaire at enrolment and at least once during the following 6 months. 69.3 % of patients were initiated on maintenance and reliever treatment. At baseline, the median ACQ-5 score was 2.0. After 6 months the median ACQ-5 score had decreased significantly to 0.6 (p < 0.0001). Similarly, after 6 months 66.1 % of patients showed improved asthma control. The proportion of subjects with poorly controlled asthma fell from 65.1 % to 17.5 %. These improvements were consistent with the 3-month follow-up results and improved lung function, QoL, treatment adherence and device satisfaction. No new safety concerns were reported.

CONCLUSION:

Results of the NEWTON study confirm the effectiveness and safety of the extrafine fixed combination of BDP/FF NEXThaler® 100/6 μg in adults with uncontrolled asthma in a real-world setting.

01 May 2025·CTS-Clinical and Translational Science

Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open‐Label, Parallel‐Group, Single‐Center Studies

Article

Author: Bellatti, Pooja ; Piccinno, Annalisa ; Balzano, Deborah ; Rostello, Chiara ; Emirova, Aida ; Rizzo, Elisa ; Pittelli, Maria Gloria

ABSTRACT:

Tanimilast is an inhaled phosphodiesterase‐4 inhibitor in development for chronic obstructive pulmonary disease and asthma. We conducted two studies to evaluate tanimilast pharmacokinetics, one in subjects with mild, moderate, or severe hepatic impairment and matched healthy controls, and one in subjects with mild, moderate, or severe renal impairment and matched healthy controls. Both studies were single‐center, open‐label, and parallel group; all subjects inhaled a single 800 μg dose of tanimilast. The primary objective was to evaluate systemic exposure of tanimilast in subjects with hepatic or renal impairment, and in matched healthy subjects, in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration–time curve from time 0 to the last quantifiable concentration (AUC0–t). A total of 44 subjects were enrolled in each study (8 with mild, moderate or severe hepatic/renal impairment, and 20 controls), all of whom completed. In the hepatic impairment study, there were no statistically significant differences in tanimilast Cmax and AUC0–t between controls and subjects with mild or moderate impairment. For severe hepatic impairment, Cmax did not differ significantly from controls, but AUC0–t increased by 104% (point estimate of ratio [90% confidence interval], 204.03 [134.36; 309.81]). In the renal impairment study, there were no statistically significant differences in tanimilast Cmax and AUC0–t between controls and subjects with mild‐to‐severe impairment. Three subjects had adverse events in each study, all mild‐to‐moderate, and none were study treatment related. These data suggest that the pharmacokinetics of tanimilast are not impacted by mild‐to‐moderate hepatic impairment, or by mild‐to‐severe renal impairment.Trial Registration:ClinicalTrials.gov (hepatic impairment NCT05373953; renal impairment NCT05431426) and EudraCT (hepatic impairment 2021‐003729‐31; renal impairment 2021‐005567‐43)

01 Jan 2025·RESPIRATORY MEDICINE

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients

Article

Author: Gálffy, Gabriella ; Kis, Erika ; Ilyés, Norbert ; Sánta, Balázs ; Horváth, Alpár ; Farkas, Árpád ; Böcskei, Renáta Marietta ; Kovács, Tamás ; Bártfai, Zoltán ; Réti, Izolda ; Havadtői, Botond

The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV₁ (%) and FEV₁/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.

News (Medical) associated with Tanimilast

16 May 2024

·www.biospace.com

Chiesi to Present New Data Showcasing Depth of Respiratory Leadership at the American Thoracic Society 2024 International Conference

Presentations will highlight new data in respiratory conditions, including asthma and chronic obstructive pulmonary disease (COPD) Data to be presented include new six-month results from a study of a single-inhaler triple therapy in patients with asthma and new pharmacokinetic studies of tanimilast, an inhaled phosphodiesterase-4 inhibitor, in patients with COPD Chiesi is a Sapphire level sponsor of the annual ATS Research Program Benefit to support new researchers in respiratory disease CARY, N.C., May 16, 2024 (GLOBE NEWSWIRE) -- Chiesi, USA (Formerly Known As Cornerstone Therapeutics) (key-A-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare Group (Chiesi Group), today announced the presentation of eight abstracts from Chiesi’s global respiratory research portfolio at the American Thoracic Society (ATS) 2024 International Conference in San Diego from May 17-22, 2024. In addition, Chiesi will showcase its commitment to innovation through additional sponsorship opportunities aimed at addressing needs within the respiratory professional community through multiple avenues, including as the largest supporter of the annual ATS Research Program Benefit. “Chiesi’s Air franchise has a robust history spanning multiple decades of delivering innovative medicines in Europe, and we’re excited to share some of the research supporting our global scientific advancements in the respiratory therapeutic area at ATS," said Carmen Dell’Anna, head of global medical affairs, Chiesi Group. "Alongside updates on our scientific progress, the Chiesi expert-led Innovation Hub will focus on discussing the role of small airway dysfunction and persistent airflow limitation in asthma. With a solid presence at the ATS conference this year, we affirm our distinctive commitment to address respiratory-related burdens by focusing on creating shared value for people and the planet.” Chiesi is presenting eight abstracts featuring the company’s latest advancements in research across asthma and chronic obstructive pulmonary disease (COPD). These presentations underscore Chiesi's dedication to advancing scientific knowledge and improving outcomes for people living with respiratory disease with preclinical and clinical stage global studies. Data accepted for presentation include: Asthma Anti-inflammatory Effects of Tanimilast in Two Murine House Dust Mite (HDM)-driven Models of Asthma Poster Session B79: Airway Smooth Muscle in Asthma (May 20, 11:30 a.m. – 1:15 p.m. PT) Extrafine Formulation Single-inhaler Triple Therapy Improves Lung Function After Six Months of Treatment in Patients With Asthma: Trimaximize Study Poster Session C31: What’s New in Clinical Asthma (May 21, 11:30 a.m. – 1:15 p.m. PT) Chronic Obstructive Pulmonary Disease (COPD) Pharmacokinetics, Safety And Tolerability Of Tanimilast Following Single Administration In Subjects With Mild, Moderate And Severe Renal Impairment Poster Session A27: Emerging Treatments and Therapeutic Strategies in COPD: Results of Clinical Trials and Observational Studies (May 19, 9:15-11:15 a.m. PT) Pharmacokinetics, Safety And Tolerability Of Tanimilast Following Single Administration In Subjects With Mild, Moderate And Severe Hepatic Impairment Poster Session A27: Emerging Treatments and Therapeutic Strategies in COPD: Results of Clinical Trials and Observational Studies (May 19, 9:15-11:15 a.m. PT) Effects Of Single Inhaler Combinations Of Extrafine BDP/FF/GB And Extrafine BDP/FF on Lung Hyperinflation And Exercise Endurance Time in Subjects With COPD Poster Session B80-2: Abnormalities in Structure and Function in COPD (May 20, 11:30 a.m.-1:15 p.m. PT) Other Respiratory Conditions Is Onsite Spirometry Quality Predicting the Quality of Home Spirometry? Poster Session A38: Highlights of Behavioral Science and Health Services Research (May 19, 11:30 a.m.-1:15 p.m. PT) Development of a Multi-biomarker Assay for Serum Proteins by the Prognostic Lung Fibrosis Consortium (PROLIFIC) Poster Session B46: Up and Coming: ILD Biomarkers (May 20, 11:30 a.m. – 1:15 p.m. PT) Proteomic Analysis of Right Ventricular Hypertrophy in Experimental Pulmonary Arterial Hypertension and the Impact of Therapeutic Intervention Poster Session C60: Beachcombing for Gold: -Omics, Inflammation, and the RV in PH (May 21, 11:30 a.m.-1:15 p.m. PT) “Despite advances in respiratory care, many individuals are waiting for new ways to address their specific asthma symptoms,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America. “The creation of innovative medicines offers increased treatment options and opportunities for treatment better tailored to an individual’s specific needs. It’s also important to address the climate crisis and take steps to directly combat the underlying environmental drivers of respiratory diseases like asthma and COPD. By tackling problems with multiple approaches, we can bridge the gap in care and achieve better outcomes for people living with respiratory disease.” In addition to presenting research, Chiesi is engaging with the respiratory healthcare community through its support of early career investigator programs. The company is a Sapphire level sponsor of the Annual ATS Research Program Benefit on Saturday, May 18, from 6-7:30 p.m. PT. Chiesi is also sponsoring a one-year research grant for a respiratory disease researcher to advance the understanding of obstructive lung disease. About Chiesi USA Chiesi USA, Inc., headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on the commercialization of products for the hospital and target office-based specialties. Chiesi USA is a wholly owned subsidiary of privately-owned Chiesi Farmaceutici S.p.A, a global R&D-focused pharmaceutical company based in Parma, Italy. In the United States, the company delivers therapies and enhances care for patients in the areas of acute cardiology, neonatology, cystic fibrosis and rare diseases. Recognized as a Certified B Corporation™, Chiesi is dedicated to improving the health and well-being of its communities through its employee-led corporate social responsibility program, Chiesi in the Community. Innovation, collaboration and impact are the cornerstones of the Chiesi culture. For more information, visit . About Chiesi Group Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and has more than 6,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit . Contacts Chiesi USA: Gentry Lassiter, +1 (984) 800-5262, us.mediarelations@chiesi.com PP-AR-0023 v1.0 PDF available:

100 Deals associated with Tanimilast

External Link

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchitis, Chronic	Phase 3	-	CHIESI Farmaceutici SpA	05 May 2021
Asthma	Phase 2	United States	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Argentina	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Bulgaria	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Czechia	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Germany	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Hungary	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Italy	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Latvia	CHIESI Farmaceutici SpA	25 Nov 2023
Asthma	Phase 2	Lithuania	CHIESI Farmaceutici SpA	25 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05431426 (ATS2024) Manual	Phase 1	Renal Insufficiency	24	tanimilast (renal impairment)	xokzijdtwb(rzhmzugfca) = There was no clear trend of increased systemic exposure with increasing RI severity frqcpdxxli (iwzcqviomc ) View more	Positive	19 May 2024
NCT04756960 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	8	CHF6001	pyikjowucm(bzgkzwgbwy) = vhgzfuhozr khsplstmag (xqcwoxcuxe, 16.7) View more	-	18 Mar 2024
ERS2019	Phase 3	Pulmonary Disease, Chronic Obstructive leukotriene B4 \| interleukin 8 \| macrophage inflammatory protein 1β ... View more	61	CHF6001 1600µg	reokpemqnn(ganukhfusr) = emggvcdkyh otqnykjbwd (zogwxykncd ) View more	Positive	28 Sep 2019
ERS2019	Phase 3		61	CHF6001 3200µg	reokpemqnn(ganukhfusr) = tzeqvxiwww otqnykjbwd (zogwxykncd ) View more	Positive	28 Sep 2019

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