Testing the effect and safety of tanimilast for COPD patients

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    What is this study about?

    This study is a year-long experiment where the researchers will test the effectiveness and safety of two doses of a new drug called tanimilast. Tanimilast is added to the usual treatment for people with two lung conditions: COPD and Chronic Bronchitis. The drug will be tested and compared with a group that will take a placebo, a substance with no effect. The main aim is to see if tanimilast helps control the worsening of symptoms in COPD patients. These worsening instances are known as ‘exacerbations’ and can range in severity. Some might require extra medication.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Durres , Albania

      Durres , Albania

      Elbasan , Albania

      Korca , Albania

      Tirana , Albania

      Tirana , Albania

      Tirana , Albania

      Tirana , Albania

      Tirana , Albania

      Tirana , Albania

      Feldbach , Austria

      Grieskirchen , Austria

      Linz , Austria

      Blagoevgrad , Bulgaria

      Gabrovo , Bulgaria

      Haskovo , Bulgaria

      Kozloduy , Bulgaria

      Lovech , Bulgaria

      Montana , Bulgaria

      Pernik , Bulgaria

      Pleven , Bulgaria

      Plovdiv , Bulgaria

      Plovdiv , Bulgaria

      Razgrad , Bulgaria

      Ruse , Bulgaria

      Ruse , Bulgaria

      Sevlievo , Bulgaria

      Sliven , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Stara Zagora , Bulgaria

      Veliko Tarnovo , Bulgaria

      Vidin , Bulgaria

      Vidin , Bulgaria

      Brandys nad Labem , Czechia

      Havlickuv Brod , Czechia

      Jindrichuv Hradec , Czechia

      Lovosice , Czechia

      Mesice , Czechia

      Miroslav , Czechia

      Mlada Boleslav , Czechia

      Olomouc , Czechia

      Prague , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Strakonice , Czechia

      Tabor , Czechia

      Varnsdorf , Czechia

      Bamberg , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Cottbus , Germany

      Darmstadt , Germany

      Delitzsch , Germany

      Essen , Germany

      Frankfurt , Germany

      Hamburg , Germany

      Hamburg , Germany

      Koblenz , Germany

      Leipzig , Germany

      Leipzig , Germany

      Leipzig , Germany

      Mainz , Germany

      Munich , Germany

      Mu00fcnster , Germany

      Peine , Germany

      Athens , Greece

      Heraklion , Greece

      Ioannina , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Volos , Greece

      Balassagyarmat , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Csorna , Hungary

      Edelu00e9ny , Hungary

      Godollo , Hungary

      Gyula , Hungary

      Monor , Hungary

      Nyu00edregyhu00e1za , Hungary

      Pu00e9cs , Hungary

      Sellye , Hungary

      Szeged , Hungary

      Szolnok , Hungary

      Szombathely , Hungary

      Szu00e1zhalombatta , Hungary

      Tatabanya , Hungary

      Brescia , Italy

      Catania , Italy

      Ferrara , Italy

      Roma , Italy

      Almere , Netherlands

      Beek , Netherlands

      Breda , Netherlands

      Leeuwarden , Netherlands

      Bialystok , Poland

      Bialystok , Poland

      Gizycko , Poland

      Katowice , Poland

      Katowice , Poland

      Krakow , Poland

      Krakow , Poland

      Krakow , Poland

      Krakow , Poland

      Lodz , Poland

      Lublin , Poland

      Ostrowiec , Poland

      Piaseczno , Poland

      Poznan , Poland

      Poznan , Poland

      Sosnowiec , Poland

      Tarnow , Poland

      Torun , Poland

      Wroclaw , Poland

      Wroclaw , Poland

      u0141u00f3du017a , Poland

      Bacau , Romania

      Bragadiru , Romania

      Cluj-Napoca , Romania

      Constanu021ba , Romania

      Craiova , Romania

      Craiova , Romania

      Deva , Romania

      Iasi , Romania

      Oradea , Romania

      Resca , Romania

      Timisoara , Romania

      Timiu0219oara , Romania

      Bardejov , Slovakia

      Humennu00e9 , Slovakia

      Kou0161ice , Slovakia

      Levice , Slovakia

      Spiu0161sku00e1 Novu00e1 Ves , Slovakia

      Barakaldo , Spain

      Madrid , Spain

      Palma De Mallorca , Spain

      Pontevedra , Spain

      Valencia , Spain

      Belfast , United Kingdom

      Bradford , United Kingdom

      London , United Kingdom

      Rochdale , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The clinical trial involves the following steps for patients, depending on the patient’s assigned treatment group:

      1. If in the group receiving CHF6001 1600μg, patients will take CHF6001 400μg, 2 inhalations twice a day (total daily dose of 1600μg).
      2. If in the group receiving CHF6001 3200μg, patients will take CHF6001 800μg, 2 inhalations twice a day (total daily dose of 3200μg).

      The duration for taking the drug or placebo, and other specific steps a patient has to follow during the trial, such as follow-up visits or monitoring, have not been provided in the quoted section, but usually, this would be explained in the informed consent documents and by the research team when enrolling in the trial. If you need more detailed information about the whole process, please let me know, and I will look further into the document.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on diseases, you need to have the following conditions:

      1. Chronic Obstructive Pulmonary Disease (COPD)
      2. Chronic bronchitis

      Additionally, you should meet certain clinical criteria related to your COPD, such as a history of exacerbations and specific lung function test results.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria

      1. Adults aged ≥ 40 years with COPD and chronic bronchitis: You must be 40 years or older and diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Chronic bronchitis is characterized by a long-term cough with mucus.
      2. Current or ex-smokers (history ≥ 10 pack years): You should have a history of smoking equivalent to at least 10 pack-years. A pack-year is defined as twenty cigarettes smoked every day for one year.
      3. Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.7: Your lung function, measured after using a bronchodilator medication to open your airways, should show that the Forced Expiratory Volume in the first second (FEV1) is less than 60% of the expected value for someone your age, race, height, and sex. Additionally, the ratio of FEV1 to the Forced Vital Capacity (FVC, the total amount of air you can forcibly exhale after taking the deepest breath possible) should be less than 0.7.
      4. At least, one moderate or severe COPD exacerbation in the previous year: You must have experienced at least one moderate or severe worsening of COPD symptoms, known as an exacerbation, in the year before joining the study.
      5. CAT score ≥ 10: Your score on the COPD Assessment Test (CAT) should be 10 or higher. The CAT is a questionnaire designed to measure the impact of COPD on a person’s life, and scores range from 0 to 40, with higher scores indicating greater disease impact.
      6. Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit: You should have been receiving a regular maintenance treatment regimen for COPD that includes three types of medication for at least 12 months before the screening and continuously for at least 3 months leading up to the screening visit

      Please let me know if you need further details on any of these criteria or have any other questions regarding the clinical study.

      What Reasons Could Exclude Me from the Study?

      You cannot take part in the study if you match any of the following conditions. I have provided explanations for some of the medical terms to help clarify their meaning:

      1. Current asthma: This refers to the presence of asthma, a chronic inflammatory disease of the airways that causes periodic episodes of wheezing, breathlessness, chest tightness, and coughing.
      2. Moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization: An increase in the severity of symptoms of chronic obstructive pulmonary disease (COPD), such as difficulty breathing, increased coughing, or increased sputum production requires specific treatments or hospitalization.
      3. Known α-1 antitrypsin deficiency as the underlying cause of COPD: A genetic disorder that may result in COPD due to low levels of α-1 antitrypsin protein, which protects the lungs from damage.
      4. COPD emphysema or mixed phenotypes: A type of COPD where the air sacs of the lungs are damaged and enlarged, causing breathlessness. Mixed phenotypes refer to a combination of different types of lung issues.
      5. Known respiratory disorders other than COPD: Having other lung diseases besides COPD.
      6. Active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy: Having currently active cancer, or a history of lung cancer where a complete recovery has not been achieved or only achieved less than a year ago.
      7. Subjects under Roflumilast treatment within 6 months before study entry: Roflumilast is a medication used to reduce inflammation in the lungs. If you’ve been on this medication in the last six months, you are excluded from participation.
      8. Diagnosis of depression, generalized anxiety disorder, suicidal ideation: Clinical diagnosis of mental health conditions that could affect study participation or results.
      9. Clinically significant cardiovascular: Having major heart-related health issues that require medical attention.
      10. Significant neurological disease: Having a major disease related to the nervous system that could interfere with the study or is a health concern.
      11. Clinically significant laboratory abnormalities: Abnormal results in clinical tests that may indicate serious health issues.
      12. Moderate or severe hepatic impairment: Having significant liver dysfunction or disease, with a decreased ability to function properly.

      Please note that this list contains medical terms which might need further clarification depending on your experience and knowledge. If you have specific questions about how these conditions apply to you, you should consult a healthcare professional.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical study involves the following drug and dosages:

      1. CHF6001 1600µg: This is an experimental drug with a total daily dose of 1600µg, administered as CHF6001 400µg, 2 inhalations twice a day (bid).
      2. CHF6001 3200µg: This is another experimental dosage of the same drug with a total daily dose of 3200µg, administered as CHF6001 800µg, 2 inhalations bid.
      3. Placebo: This is a placebo matching the CHF6001 to be administered as 2 inhalations bid.

      The active substance in the drug CHF6001 is Tanimilast, which is a phosphodiesterase 4 (PDE4) inhibitor. PDE4 inhibitors have anti-inflammatory effects, and they are used in the treatment of conditions such as chronic obstructive pulmonary disease (COPD) by reducing exacerbations related to respiratory inflammation.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial in question is evaluating the efficacy and safety of Tanimilast (CHF6001) as an add-on to maintenance triple therapy in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. Below is a list of substances being tested and their current status in medical literature:

      1. Tanimilast (CHF6001): Tanimilast is a drug that is not yet widely known or established in medical literature for the treatment of COPD. It appears to be a novel substance undergoing evaluation in this clinical trial for its efficacy and safety as an add-on therapy.

      Study ID

      CT-EU-00041448

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases