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

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What is this study about?

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.

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

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

3 Laboratory tests

Blood tests will check standard health parameters

Additional tests may be performed if deemed necessary by the medical staff

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 Study?

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 Study?

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)

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Mvzdxjfg Mnranpq Aunlvhl	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.03.2025

Trial locations

Investigated drugs:

Tanimilast

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.

Investigated diseases:

Asthma

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.

Trial ID:

2024-516483-29-00

Protocol code:

CLI-06001AC1-01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?