Not recruiting

Study comparing absorption of inhaled Tanimilast (CHF 6001) in adolescent and adult asthma patients

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with asthma, comparing how the medication works in both adolescents and adults. The investigational treatment is CHF6001, which is administered as an inhalation powder using a special device called NEXThaler. The active substance in the medication is tanimilast.

The purpose of this research is to understand how CHF6001 is processed by the body in adolescents with asthma compared to adults with asthma. The study involves a single dose of the medication through inhalation. Both adolescent and adult participants must have stable asthma that has been treated with standard asthma medications for some time before joining the study.

During the study, participants will receive one dose of the study medication through inhalation. The researchers will take blood samples over time to measure how the medication moves through the body. They will also monitor heart activity, blood pressure, and check for any possible side effects. The study requires only a few visits to the study center, including a screening visit, a treatment day, and a follow-up visit.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial study visit
You will receive a single dose of CHF 6001 (3200 μg) using a device called NEXThaler
The medication will be administered through inhalation (breathing in through the device)
Before taking the medication, you will need to avoid using your regular asthma inhaler: short-acting inhalers for 6 hours, or long-acting inhalers for 24 hours
Step 2
Monitoring period - first 10 hours
Your heart will be monitored through ECG measurements multiple times
Your blood pressure will be checked at several points
Blood samples will be collected to measure how the medication moves through your body
Step 3
Laboratory tests
Blood tests will check standard health parameters
Additional tests may be performed if deemed necessary by the medical staff
Step 4
Follow-up visit
A final check of your health status will be conducted
Any side effects that occurred during the study will be reviewed
Final blood pressure and heart measurements will be taken

Who can join the trial?

9 criteria

Must provide written informed consent (for participants under 18, consent from parents or legal guardian is required)
Age requirements: - Adolescents: between 12 and 17 years old - Adults: between 18 and 75 years old
Weight requirements: - For 12-year-olds: at least 19 kg - For 13-17 year-olds: at least 30 kg
For adult participants: Body Mass Index (BMI) must be between 18.0 and 30.0
Must have documented asthma diagnosis for at least 1 year (for adults, diagnosed before age 50)
Must be on stable asthma treatment for at least 3 months before screening with medium-dose inhaled corticosteroids (ICS)
Lung function requirement: FEV1 (amount of air you can forcefully exhale in one second) must be above 70% of predicted normal value
Must be able to: - Use inhalers correctly - Perform breathing tests according to required standards
For female participants: - Women who cannot become pregnant, or - Women who can become pregnant must use effective birth control methods during the study - Women with non-fertile partners do not need contraception

Who cannot join the trial?

15 criteria

Current or past history of severe asthma (requiring frequent hospitalizations or emergency room visits)
Any respiratory tract infection within 4 weeks before the study start
History of life-threatening asthma requiring intubation (insertion of breathing tube)
Pregnancy or currently breastfeeding
Use of any investigational drug within 30 days before the study
Known allergic reactions to similar inhaled medications
Significant heart, liver, or kidney disease
Current smoking or history of smoking within past 6 months
Unable to properly use the NEXThaler® inhaler device
Any condition that could interfere with the study medication absorption
Blood disorders that could affect study results
Regular use of medications that could interact with the study drug
History of drug or alcohol abuse within the past 2 years
Mental conditions that could affect ability to follow study instructions
Inability to provide informed consent (written permission to participate)

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Military Medical Academy
Verified
Pleven, Bulgaria

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

CHF 6001
is an inhaled medication being studied for asthma treatment. It is administered using a device called NEXThaler®, which is an inhaler that delivers the medicine directly to the lungs. This medication is being investigated to understand how it works in both adolescent and adult patients with asthma.
NEXThaler®
is a dry powder inhaler device used to deliver the medication to the lungs. It is designed to be easy to use and helps ensure that patients receive the correct amount of medicine with each inhalation.

Tanimilast

What is already known about the treatment

CHF 6001 - An investigational inhaled medication administered via the NEXThaler® device, specifically being studied for the treatment of asthma. This drug is currently undergoing clinical trials to evaluate its pharmacokinetic profile in both adolescent and adult asthma patients. While the exact molecular mechanism is still under investigation, it belongs to the class of inhaled respiratory medications designed for asthma management. The 3200 μg dose delivered through oral inhalation represents a specific formulation being tested to determine its effectiveness and safety profile in different age groups of asthma patients.

Investigated diseases

Asthma - A chronic respiratory condition characterized by inflammation and narrowing of the airways. The condition causes recurring episodes where the airways become constricted, leading to breathing difficulties, wheezing, coughing, and chest tightness. During an asthma episode, the airway muscles tighten, the lining of the airways becomes swollen, and excess mucus is produced. The severity and frequency of symptoms can vary from person to person, with some experiencing mild occasional symptoms while others have more frequent episodes. Environmental triggers, such as allergens, exercise, or respiratory infections, can initiate or worsen asthma symptoms.