Study of the effectiveness of tanimilast in the treatment of pulmonary diseases

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    What is this study about?

    A 52-week clinical trial is being conducted to investigate the effectiveness and safety of the new drug, known as Tanimilast (CHF6001), in people diagnosed with chronic bronchitis and chronic obstructive pulmonary disease (COPD). The primary aim of the study is to determine the effectiveness of CHF6001 administered as an addition to a standard COPD treatment regimen. Study participants will be randomly assigned to receive the study drug CHF6001 or a placebo, which will be taken concurrently with their existing COPD therapy. Key measurements in the study include monitoring the frequency and severity of COPD exacerbations, which are episodes of significantly worsening symptoms. Additionally, the study will assess changes in participants’ lung function and overall quality of life. Typically eligible for the study are adults who are 40 years of age or older, have a documented history of COPD and chronic bronchitis, and are current or former smokers. In particular, the study is of interest to people who have experienced at least one COPD exacerbation in the year preceding the study.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Feldbach , Austria

      Grieskirchen , Austria

      Linz , Austria

      Blagoevgrad , Bulgaria

      Dimitrovgrad , Bulgaria

      Gabrovo , Bulgaria

      Haskovo , Bulgaria

      Kozloduy , Bulgaria

      Lovech , Bulgaria

      Montana , Bulgaria

      Pernik , Bulgaria

      Pleven , Bulgaria

      Plovdiv , Bulgaria

      Razgrad , Bulgaria

      Ruse , Bulgaria

      Ruse , Bulgaria

      Sevlievo , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Vidin , Bulgaria

      Vidin , Bulgaria

      Brandu00fds Nad Labem , Czechia

      Havlu00edu010dku016fv Brod , Czechia

      Jindu0159ichu016fv Hradec , Czechia

      Miroslav , Czechia

      Mladu00e1 Boleslav , Czechia

      Mu011bu0161ice , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Praha , Czechia

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Darmstadt , Germany

      Delitzsch , Germany

      Frankfurt Am Main , Germany

      Geesthacht , Germany

      Hamburg , Germany

      Hamburg , Germany

      Leipzig , Germany

      Leipzig , Germany

      Leipzig , Germany

      Mainz , Germany

      Munich , Germany

      Peine , Germany

      Athens , Greece

      Chortiu00e1tis , Greece

      Heraklion , Greece

      Ioannina , Greece

      Thessalonu00edki , Greece

      Volos , Greece

      Balassagyarmat , Hungary

      Budapest , Hungary

      Csorna , Hungary

      Edelu00e9ny , Hungary

      Gu00f6du00f6llu0151 , Hungary

      Monor , Hungary

      Nyu00edregyhu00e1za , Hungary

      Pu00e9cs , Hungary

      Sellye , Hungary

      Szeged , Hungary

      Szombathely , Hungary

      Breda , Netherlands

      Heerlen , Netherlands

      Leeuwarden , Netherlands

      Bialystok , Poland

      Giu017cycko , Poland

      Katowice , Poland

      Katowice , Poland

      Krakow , Poland

      Kraku00f3w , Poland

      Kraku00f3w , Poland

      Ostrowiec u015awiu0119tokrzyski , Poland

      Poznau0144 , Poland

      Poznau0144 , Poland

      Sosnowiec , Poland

      Torun , Poland

      Wrocu0142aw , Poland

      u0141u00f3du017a , Poland

      u0141u00f3du017a , Poland

      Cluj-Napoca Cluj , Romania

      Constanu0163a , Romania

      Craiova , Romania

      Iau015fi , Romania

      Resca , Romania

      Timisoara , Romania

      Bardejov , Slovakia

      Kou0161ice , Slovakia

      Spiu0161sku00e1 Novu00e1 Ves , Slovakia

      Barcelona , 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?

      Based on the information provided about this clinical trial, here are the key steps a patient would likely need to take:

      1. Enrollment: The patient must meet the inclusion criteria (e.g. age 40+, diagnosed with COPD and chronic bronchitis, smoking history, recent COPD exacerbation, etc.) and not have any exclusion criteria. They would need to provide informed consent to participate.

      2. Randomization: The patient will be randomly assigned to one of four treatment groups:
      – CHF6001 1600μg (2 inhalations twice daily)
      – CHF6001 3200μg (2 inhalations twice daily)
      – Placebo (2 inhalations twice daily)
      – Roflumilast (1 tablet daily, 250μg first 4 weeks then 500μg after)

      3. Treatment Period (52 weeks):
      – The patient will need to take their assigned study medication (CHF6001, placebo, or roflumilast) for the full 52 weeks as directed.
      – This involves twice daily inhalations for CHF6001/placebo groups and one daily tablet for the roflumilast group.
      – During the 52 weeks, data will be collected on COPD exacerbations, lung function, quality of life scores, rescue medication use, adverse events, etc.

      4. Follow-up: After completing the 52 week treatment period, the patient will likely have a follow-up visit for final assessments.

      So in summary, the key commitment for a patient is taking the assigned study drug consistently for 52 weeks and attending periodic study visits for assessments. The exact visit schedule is not provided but these trials typically involve visits every few months during the treatment phase.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria, to join this study you need to have the following diseases:

      • COPD (Chronic Obstructive Pulmonary Disease)
      • Chronic bronchitis

      The study excludes people with certain other respiratory diseases like:

      • Current asthma
      • α-1 antitrypsin deficiency as the underlying cause of COPD
      • Primary diagnosis of emphysema not related to COPD
      • Other known respiratory disorders besides COPD

      It also excludes people with active cancer or a history of lung cancer. But the key diseases needed to participate are COPD with chronic bronchitis.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join this study, you must meet the following inclusion criteria:

      Age and COPD Diagnosis:

      • You must be 40 years old or older
      • You must be diagnosed with COPD (Chronic Obstructive Pulmonary Disease, a lung disease that causes airflow blockage and breathing problems)
      • You must have chronic bronchitis (long-term inflammation of the bronchi, the airways in the lungs)

      Smoking History:

      • You must be a current smoker or an ex-smoker
      • You must have a smoking history of at least 10 pack years (1 pack year = smoking 20 cigarettes per day for 1 year)

      Lung Function Tests:

      • Your FEV1 (Forced Expiratory Volume in 1 second, a measure of how much air you can exhale in 1 second) must be less than 50% of the predicted normal value for you
      • Your FEV1/FVC ratio (FEV1 divided by Forced Vital Capacity, the total amount of air exhaled) must be less than 0.7

      Exacerbation History:

      • You must have had at least one moderate or severe COPD exacerbation (worsening of COPD symptoms) in the previous year

      CAT Score:

      • Your CAT (COPD Assessment Test) score must be 10 or higher. The CAT is a questionnaire used to measure the impact of COPD on a person’s life and ranges from 0-40, with higher scores indicating a more severe impact

      Current Treatment:

      • You must have been on regular maintenance triple therapy (a combination of three different types of COPD medications) for at least 12 months

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in the study if you have any of the following:

      Lung Conditions:

      • Current asthma – a chronic lung disease that causes episodes of difficult breathing
      • Known α-1 antitrypsin deficiency as the underlying cause of COPD – a genetic disorder that can lead to lung and liver disease
      • Primary diagnosis of emphysema not related to COPD – a lung condition that causes shortness of breath due to damage to the air sacs
      • Known respiratory disorders other than COPD – any lung diseases besides COPD
      • Lung volume reduction surgery – a surgical procedure to remove damaged parts of the lungs

      Other Medical Conditions:

      • Active cancer or a history of lung cancer
      • Diagnosis of depression, generalized anxiety disorder, or suicidal ideation – mental health conditions
      • Clinically significant cardiovascular condition – serious heart problems
      • Neurological disease – disorders affecting the brain, spinal cord, or nerves
      • Clinically significant laboratory abnormalities – abnormal blood test results that could indicate health issues
      • Moderate or severe hepatic impairment – reduced liver function

      Recent COPD Exacerbation or Medication:

      • Moderate or severe COPD exacerbation 4 weeks before study entry and randomization – worsening of COPD symptoms requiring additional treatment
      • Roflumilast treatment within 6 months before study entry – an oral medication used to reduce inflammation in COPD patients

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The following drugs are involved in the study:

      • CHF6001 (Tanimilast): An investigational drug that is a PDE4 inhibitor and anti-inflammatory respiratory drug. It is being evaluated at two doses (1600μg and 3200μg) as an add-on to maintenance triple therapy in patients with COPD and chronic bronchitis.
      • Roflumilast (Daliresp®): An FDA-approved PDE4 inhibitor used as an active comparator in this study. Patients in the Roflumilast arm receive 250μg once daily for the first 4 weeks, then 500μg once daily for the remaining treatment period.
      • Placebo: Patients in the placebo arm receive matching placebos for both CHF6001 and Roflumilast.

      The study aims to compare the efficacy and safety of two doses of CHF6001 (Tanimilast) against Roflumilast and placebo when added to standard maintenance triple therapy in patients with COPD and chronic bronchitis.

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

      Based on the information provided in the clinical trial description, the active substances participating in this study include:

      1. CHF6001 (Tanimilast):
        • This appears to be an investigational drug being studied in this trial. As an investigational drug, it is likely not yet well established in medicine and the medical literature.
      2. Roflumilast (Daliresp):
        • Roflumilast is an FDA-approved drug used to decrease the frequency of flare-ups or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). As an approved drug, it is already known to medicine and described in the medical literature.

      In summary, the trial is studying a combination of an investigational drug (CHF6001) along with an established, approved drug (roflumilast) for the treatment of COPD with chronic bronchitis.


      Study ID

      CT-EU-00041455

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases