Study on the Effectiveness and Safety of CHF6001 DPI with Roflumilast for Patients with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

3 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Chronic Obstructive Pulmonary Disease (COPD), specifically in patients who also have chronic bronchitis. The treatment being tested is called CHF6001 DPI, which is an inhalation powder containing the active substance tanimilast. The study will also involve a medication called Roflumilast (Daliresp®), which is available in tablet form. Some participants will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to evaluate how effective and safe two different doses of CHF6001 DPI are when added to the usual maintenance therapy for COPD. This maintenance therapy typically includes a combination of inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA). The study will last for 52 weeks, during which participants will be randomly assigned to different groups. Some will receive CHF6001 DPI along with their regular treatment, while others will receive Roflumilast or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed.

Throughout the study, participants will be monitored to see how the treatments affect their COPD symptoms, particularly the frequency and severity of flare-ups, also known as exacerbations. The study will also assess changes in lung function and quality of life. By the end of the study, researchers hope to determine whether adding CHF6001 DPI to the standard COPD treatment can help reduce the number of moderate and severe exacerbations in patients with COPD and chronic bronchitis.

1 joining the study

Upon joining the study, participants are required to provide written informed consent. This confirms understanding of the study procedures and agreement to participate.

Participants must be at least 40 years old and have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes a review of medical history, smoking history, and current symptoms.

Participants must have a history of at least one moderate or severe COPD exacerbation in the previous year and be on maintenance triple therapy for at least 12 months prior to the screening.

3 randomization and treatment allocation

Participants are randomly assigned to one of the treatment groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

The study involves the use of CHF6001 DPI, Roflumilast (Daliresp®) 500µg, and Roflumilast (Daliresp®) 250µg, as well as corresponding placebos.

4 treatment administration

Participants receive their assigned treatment for a duration of 52 weeks. CHF6001 DPI is administered via inhalation, while Roflumilast is taken orally in tablet form.

The frequency and dosage depend on the specific treatment group to which the participant is assigned.

5 ongoing monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the efficacy and safety of the treatment. This includes spirometry tests and questionnaires to evaluate symptoms and quality of life.

Participants are required to use electronic devices to complete COPD questionnaires and perform required outcome measurements.

6 completion of the study

At the end of the 52-week period, participants complete a final assessment to evaluate the overall impact of the treatment.

The primary goal is to measure the annual rate of moderate and severe exacerbations, while secondary goals include changes in symptom scores and lung function.

Who Can Join the Study?

  • Males and females aged 40 years or older who have given written permission to participate in the study.
  • Participants must be willing and able to learn how to use electronic devices for answering questions about their condition and performing necessary tests, like breathing tests.
  • Women can join the study if they cannot have children or, if they can have children, they must have a negative pregnancy test and agree to use birth control.
  • Participants must have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis.
  • Current smokers or those who quit smoking at least 6 months before the study, with a history of smoking at least 10 pack years. A “pack year” is a way to measure how much someone has smoked over time.
  • Participants must have a specific lung function test result, showing less than 50% of the expected normal value after using a medicine that helps open the airways.
  • Participants must have had at least one moderate or severe worsening of their COPD in the past year, as confirmed by medical records.
  • Participants must have symptoms at the start of the study, shown by a CAT score of 10 or more. The CAT score is a questionnaire that measures the impact of COPD on a person’s life.
  • Participants must have been prescribed a combination of three types of COPD medicines (ICS, LABA, LAMA) for at least 12 months before the study and have been regularly using them for at least 3 months before the study starts. ICS must be in an approved dose for COPD.
  • Participants must be willing and able to learn how to use a specific type of inhaler called DPI inhalers (NEXThaler®).

Who Cannot Join the Study?

  • Patients who have a different lung condition other than Chronic Obstructive Pulmonary Disease (COPD).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have a medical condition that might interfere with the study results or pose a risk to their health.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of substance abuse that might affect their ability to participate in the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Frisius Heerenveen The Netherlands
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Research Center for Medical Studies (RCMS) Berlin Germany
Hospital Clinico San Carlos Madrid Spain
Trial Pharma Kft. Gyula Hungary
Pneumologisches Studienzentrum München-West Munich Germany

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Alergologia Plus Sp. z o.o. Poznan Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Daugavpils regionala slimnica SIA Daugavpils Latvia
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj Napoca Romania
Policum Berlin Studien GmbH Berlin Germany
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Ruse Bulgaria
Pneumo Studien Darmstadt GmbH Darmstadt Germany
National Multidisciplinary Transport Hospital Tsar Boris III Sofia Bulgaria
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Opca Bolnica Dubrovnik Dubrovnik Croatia
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Berlin Germany
MediTrial s.r.o. Jindřichův Hradec Czechia
MUDr. Ilona Pavlisova s.r.o. Miroslav Czechia
MEDICON a.s. Prague Czechia
Klifeck GmbH Delitzsch Germany
POIS Sachsen GmbH Leipzig Germany
MECS Medical and Clinical Studies Cottbus GmbH Cottbus Germany
Latvijas Universitates Mediciniskas Pecdiploma Izglitibas Instituts SIA Riga Latvia
Pro Familia Altera Sp. z o.o. Katowice Poland
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet Balassagyarmat Hungary
Erzsebet Gondozohaz Kft. Godollo Hungary
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
MC Re Spiro OOD Razgrad Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD Dimitrovgrad Bulgaria
KBC Zagreb Zagreb Croatia
General University Hospital Of Larissa Larissa Greece
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
University Teaching Hospital Markusovszky Szombathely Hungary
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Rigas 1. slimnica SIA Riga Latvia
Opca Bolnica Zadar Zadar Croatia
University General Hospital Of Ioannina Ioannina Greece
Clinical Medical Center Osijek Osijek Croatia
Opca Bolnica Karlovac Karlovac Croatia
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Tartu University Hospital Tartu Estonia
Kepler Universitaetsklinikum GmbH Linz Austria
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Pratia S.A. Skorzewo Poland
Specijalna Bolnica Medico Rijeka Croatia
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Veselibas centru apvieniba AS Riga Latvia
Poliklinika Solmed d.o.o. Zagreb Croatia
KBC Split Split Croatia
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Leipzig Germany
University Of Szeged Szeged Hungary
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
North Estonia Medical Centre Foundation Tallin Estonia
MUDr. I. Cierna Peterova s.r.o. Brandys Nad Labem Czechia
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k. Cracow Poland
Medical Center Sun I Zdrave Ltd. Sofia Bulgaria
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Balvu un Gulbenes slimnicu apvieniba SIA Balvi Latvia
D A W O N spol. s r.o. Prague Czechia
Poliklinika pod Marjánkou Prague Czechia
Ctcvwbx Moykkcu Dw Daxoxtwrqb Sr Tafbetjqb Alfwojfiv Nungdg Sbewuh Brasov Romania
Mhuqdfa Cxefys Pkdidr Cnjbci Eisl Lovech Bulgaria
Opdkijjuadvl Chjhdec Mbwcuies Ahan Owjzg Cvkaoy Krpwqedso Cbzbbi sjxe Ostrowiec Swietokrzyski Poland
Oixj Bsflmwo Dhk Izv Pxjcgjd Sxmjj Sisak Croatia
Ouaakpcg nidkgldmu Mzqid Bjnxiqdt aegw nejrtaevn Ssxphwilbtpex kkrky Mlada Boleslav Czechia
Olzjnaes cdvsre phxahxjg slgasc Prague Czechia
Nyfaebfqm Mmjgbk Cbhqieo iycuzjssrrp owzciomqcpv pmnx zhar Mesice Czechia
Phjyih owhkfbjz spiwre Havlickuv Brod Czechia
Nbdfg Hazlgrhx Narva Estonia
Pnynckzzqznuqw Pcfcfy uyq Swirqvldgya Lxwp Vzyscrcf utc Kvorypqk Hanover Germany
Lqlkzhrqdcisu Gbturrzoju Geesthacht Germany
Mb Cdvgpnwt Rozurpkjkpw Rjtmfnxq Hfuzfna Gyuz Hamburg Germany
Djl Mivm Fifw Bezburb Fcnhzegd Fzof Ifilrs Mjbuytf Upi Puftksqbnyr Leipzig Germany
Pwkkel az dxw Ogzl Berlin Germany
Vsipgq Vskbksqhm &wpkxih arinn plipqf pbfcgrdqjimizi ut amnaqlwnqqfh Rezekne Latvia
Cpwzmc Rjmpa Mvpydmn Sgthme Cluj Napoca Romania
Sptqduhr Dd Pxiplfzqlhrlvejbz Bymlo Bacau Romania
Cqd Pmuxreffryf Dyx Mszbv Boppgm Mhzwy Cluj Napoca Romania
Ndzzvsybvd Sgubhs Iasi Romania
Ogvdsadzxy Djh Mfqxepk Wlfrw Fpvycitt fsg Lcijalltzryplgyuc Linz Austria
Rboijpc Kyuw Nyiregyhaza Hungary
Puwj Menyar Jjvj Vuwrm Eyjcwbrukc Efjnurxdedpre Ivltaeekpuw Pecs Hungary
Imeixkiph Tufqjhfqrz Ktxavgtehtxv él Stvmokmdsou Khyo Sellye Hungary
Ébmchymugujuaiihl Cxwlndi Úk Sbzqc Jznul Kzjgrq és Sfwruzleykb Budapest Hungary
Soppmmzbrgn Hgnhznfv Fxq Aopdij Tmpnevtbl Os Pyersfzgb Drzxffuo Pmywvg Epzw Pernik Bulgaria
Mulzwgi Cgodpw Fgzi Mcqddok Euns Plovdiv Bulgaria
Mrzomve Crqfqv Slxvx Diksolu – Vsgoi Oke Vidin Bulgaria
Mwembqj Clkwmk Sro Ifgm Rfolie Ejoc Vidin Bulgaria
Mkwqhaceghiua Hejdkpls fqm Ayewqq Txiikqyeb Lomqr Efn Sofia Bulgaria
Sfzkdksrvqz Hzedgitc Fpb Aoqkhj Toqduxffq Oa Pfhohxcotvanqqogif Dxggttca Hscakdb Exwj Haskovo Bulgaria
Mdzeqyfsc Imdryltqqd Ceuqzhys Sibogpaf Sfp z ojeb Warsaw Poland
Pytfxts Tafns &ceko Ryxratloolz Bgvk Beek Lb The Netherlands
Scbrpyvvdduuxs Div mxjx Slkejqsos Peine Germany
Svuvlmlz Caezwb Dj Pizpmwvoxzplfefrg Cnpzvvyec Palazu Mare Romania
Pztejsfn arsslfjvod Hmilafyz skrsww Spisska Nova Ves Slovakia
Sukkykzyxv bvoszdw Pjrzpevr Zagreb Croatia
Kypkgfan bffueszm cwghse Ryyhcl (mepjgopn Hzjtymed Cmhibz Rkvkpaf Rijeka Croatia
Nrh Svn Jnqomm Bomhuiul nlmt Bardejov Slovakia
Ptvkzx Gcgqvuol Gpdeum Mpduphb Kaenggxa sjyl Sosnowiec Poland
Nawc Melitq Jdnzl Cqpgkk Giżycko Poland
Aemkhe Mgoawfr Corjox Shnc Thessaloniki Greece
Mhsoixdg Mdufmge Apfvble Pleven Bulgaria
Hxuafgrg Dt Lo Ssbsi Crxu I Sbes Pcr Barcelona Spain
Ffdcmvmy Ceqpczhbnevci Timisoara Romania
Mxqhyj Hixblz Ctgptd Svjhm Eemd Sofia Bulgaria
Ksmy Gpcl Bendorf Germany
Mjcqykb sgtcyn Kosice Slovakia
Onldqizytz Dfh Reuezc Vubwg Feldbach Austria
Ouluhluiur Dgq Pjvpc Wzxze Grieskirchen Austria
Sdepuvit dn Pjcuexzjcrj Dpj Lrcnjgf Dpbctvobu Sdcnw Oradea Romania
Cl Pneqvt Bdzkab Mks Timisoara Romania
Csatcdco Hihdrvpl Dbvnxlc Zagreb Croatia
Sbwfmhdw Cqcrve Dq Bply Ixbodgrwysm Sm Pbalvldvgyenixxzi Vuqwwn Bxtcm Cfivihe Craiova Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.06.2021
Bulgaria Bulgaria
Not recruiting
30.06.2021
Croatia Croatia
Not recruiting
30.06.2021
Czechia Czechia
Not recruiting
30.06.2021
Estonia Estonia
Not recruiting
30.06.2021
Germany Germany
Not recruiting
30.06.2021
Greece Greece
Not recruiting
30.06.2021
Hungary Hungary
Not recruiting
30.06.2021
Latvia Latvia
Not recruiting
30.06.2021
Poland Poland
Not recruiting
30.06.2021
Romania Romania
Not recruiting
30.06.2021
Slovakia Slovakia
Not recruiting
30.06.2021
Spain Spain
Not recruiting
30.06.2021
The Netherlands The Netherlands
Not recruiting
30.06.2021

Trial locations

Investigated drugs:

Roflumilast: This medication is used to reduce inflammation in the lungs and is often prescribed for people with severe Chronic Obstructive Pulmonary Disease (COPD) to help prevent flare-ups. It works by decreasing swelling and irritation in the airways, making it easier to breathe.

Daliresp: This is a brand name for roflumilast, which is used to treat COPD. It helps to prevent the worsening of symptoms by reducing inflammation in the lungs.

CHF6001: This is an investigational medication being studied as an add-on treatment for COPD. It is being tested to see if it can further reduce the frequency of moderate and severe exacerbations when used alongside standard maintenance therapy. The goal is to improve breathing and reduce the number of flare-ups in patients with COPD and chronic bronchitis.

ICS, LABA, LAMA: These are types of medications commonly used in combination as maintenance therapy for COPD. ICS stands for inhaled corticosteroids, which help reduce inflammation in the airways. LABA stands for long-acting beta-agonists, which help relax the muscles around the airways to keep them open. LAMA stands for long-acting muscarinic antagonists, which also help to keep the airways open by blocking certain receptors in the lungs. These medications are often used together to help manage COPD symptoms and prevent exacerbations.

Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, which is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. The main symptoms include breathing difficulty, cough, mucus (sputum) production, and wheezing. People with COPD are at increased risk of developing heart disease, lung cancer, and a variety of other conditions. The disease progresses over time, leading to worsening symptoms and decreased lung function. Exacerbations, or episodes of worsening symptoms, are common and can be triggered by infections or environmental pollutants.

Trial ID:
2023-510174-13-00
Protocol code:
CLI-06001AA1-05
NCT ID:
NCT04636814
Trial Phase:
Therapeutic confirmatory (Phase III)

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