AsthmaPhase 2NCT06900816
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
A Phase 2 study testing CHF 6001 in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF 6001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 28 Mar 2025to 11 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent: subject's and/or parents or legal representative (for adolescents) written informed consent obtained prior to any study-related procedures.
- Sex and age: a. Adolescent: male or female subjects aged ≥12 and <18 years; b. Adult: male or female subjects aged ≥18 and ≤75 years.
- Body weight for adolescents within the range of ≥34.7 kg for 12 years old and ≥40.4 kg for 13 to 17 years old.
- Body mass index for adults within the range of ≥18.0 to ≤30.0 kg/m2.
- Diagnosis of asthma: a documented history of physician diagnosed asthma according to international guidelines (GINA) update 2024 for ≥1 year, with diagnosis before the age of 50 years for adults.
- Stable asthma therapy: a stable treatment with medium dose of inhaled corticosteroids (ICS) (medium-dose ICS defined as beclometasone dipropionate [BDP] non-extrafine >500 to 1000 μg or estimated clinical comparable dose as per GINA guidelines update 2024) alone or in fixed combination with a Long-acting β2-agonist (LABA) with or without long-acting muscarinic antagonist (for subjects ≥18 years old only) for ≥3 months before screening.
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- Lung function: adolescent and adult subjects with a Forced Expiratory Volume in 1 Second (FEV1) >70% of predicted values (% predicted) after withholding short-acting β2-agonist (SABA) treatment for a minimum of 6 hours before screening or 24 hours in case of ICS and LABA (alone or in fixed combination).
- A cooperative attitude and ability: a. To correctly use the inhalers; b. To perform all study-related procedures including technically acceptable spirometry according to the 2019 American Thoracic Society (ATS)/ European Respiratory Society (ERS) guidelines.
- Female subjects fulfilling one of the following criteria: a. Women of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e., postmenopausal or permanently sterile, as per definitions given in Section 1.1 of the Clinical Trials Coordination Group (CTCG) guidance). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator's request, postmenopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). b. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up (FU) visit or; ii. WOCBP with non-fertile male partners (contraception is not required in this case). For the definition of WOCBP, fertile men and the list of highly effective birth control methods, refer to or Section 1.1 and 4.1 of the CTCG guidance.
Who cannot join
- Blood donation (≥450 mL) or blood loss, less than 2 months before screening or before enrolment on Day 1, applicable for adults only.
- History of "at risk" asthma: history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the Investigator, may place the subject at undue risk.
- Recent exacerbation or respiratory tract infection: hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks before the screening visit. Note: Subjects experiencing an exacerbation or respiratory tract infection during the screening visit may be rescreened once, ≥6 weeks after recovery. If there is no recovery, such event constitutes an exclusion criterion and leads to screening failure.
- Subjects using systemic corticosteroid medication 4 weeks or slow release corticosteroids 12 weeks before enrolment.
- Patients being treated with anti-inflammatory asthma monoclonal antibodies or biological drugs which can affect asthma inflammation within 6 months before or five half-lives (whichever is greater) before the screening visit.
- Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma. This can include, but is not limited to, Chronic Obstructive Pulmonary Disease (COPD), α1-antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease and others.
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- Smoking status: current smoker, ex-smoker with a smoking history of ≥10 pack-years (pack-years = the number of cigarette packs per day times the number of years) or current use of inhaled or oral cannabis products. Ex-smokers must have stopped smoking for ≥1 year (≥6 months for e-cigarettes).
- Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/or drug abuse within 12 months before screening.
- Cancer or history of cancer: subjects with active cancer or a history of cancer with <5 years disease free survival time (whether there is evidence of local recurrence or metastases). Localised carcinoma (e.g., basal cell carcinoma, in situ carcinoma of the cervix adequately treated) is acceptable.
- Cardiovascular disease: subjects who have clinically significant (CS) cardiovascular condition according to Investigator's judgement, such as heart failure (New York Heart Association class >3), acute ischemic heart disease in the last year prior to screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months prior to screening (sustained means lasting >30 seconds or ending only with external action, or leads to haemodynamic collapse; nonsustained means >3 beats <30 seconds, and/or ending spontaneously and/or asymptomatic), high degree impulse conduction blocks (>2nd degree atrioventricular block type 2). Similarly, subjects affected by persistent, long-standing or paroxysmal atrial fibrillation will not be considered for enrolment. Note: Subjects with permanent atrial fibrillation (for ≥6 months before the screening visit) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) can be considered for enrolment.
- Electrocardiogram (ECG) criteria: an abnormal and CS 12-lead ECG that in the Investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk. Male subjects whose 12-lead ECG shows Fridericia's Corrected QT Interval (QTcF )>450 ms or female subjects with a QTcF >460 ms (adolescent females) or >470 ms (adult females) at screening or at enrolment (criterion not applicable for subjects with pacemaker or permanent atrial fibrillation).
- Other severe acute or chronic medical or malignancy or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Liver diseases: subjects with severe hepatitis, chronic active hepatitis or evidence of uncontrolled chronic liver disease according to the Investigator's opinion.
- Drugs with hepatoxicity potential: subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity (i.e., isoniazide, nimesulide, ketoconazole) and strong inhibitors of cytochrome P450 (CYP) 3A4/5 (i.e., itraconazole) within the previous 3 months before the screening visit.
- Subjects having received a vaccination within 2 weeks before the screening visit.
- Subjects with major surgery in the 3 months before the screening visit or planned surgery during the study.
- Subjects with a history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- Subjects treated with monoamine oxidase inhibitors or tricyclic antidepressants.
- Subjects treated with non-potassium sparing diuretics (unless administered as a fixed dose combination with a potassium conserving drug or changed to potassium sparing agent before the screening), non-selective beta blocking drugs, quinidine, quinidine-like anti-arrhythmics or any medication with a Corrected QT Interval (QTc) prolongation potential or a history of QTc prolongation.
- Subjects who are receiving any therapy that could interfere with the study treatments according to Investigator's opinion.
- Subjects who have received an investigational drug within 30 days or five half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study or are currently participating in another study.
- Documented coronavirus disease 2019 diagnosis within the last 2 weeks, or associated complications or symptoms, which have not resolved within 14 days before screening.
- For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test at screening visit and urine test at Day 1.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical Centre Comac Medical Ltd.
Sofia, Krasno Selo District, 1612
About this study
Official title: A Single-centre, Single-dose, Open Label, Non-randomized, Parallel Group, Clinical Pharmacology Study of CHF 6001 in Asthmatic Adolescent Patients and in Asthmatic Adult Patients as Control Group
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
Read the detailed description
The study plan foresees a total of four visits at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be trained to assess their ability to use an inhaler device and to teach the inhaling technique. At the following visit, the patients will inhale through the device and amount of the study drug and of its metabolites in the blood will be measured at different times after inhalation. At a subsequent ambulatory visit, the final measurements will be performed. A follow-up Visit will be done to check patients safety and wellbeing, 12 to 14 days after the study treatment intake. A total of 25 asthmatic adults (≥18 years), and 25 asthmatic adolescents ( ≥12 and <18 years) with a stable asthma therapy according to international guidelines Global Initiative for Asthma (GINA) (update 2024), will be enrolled.
- Conditions
- Asthma
- Being tested
- CHF 6001
- Keywords
- CHF6001, pharmacokinetics, adolescents, patients
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 6001Drug
CHF 6001 DPI single dose
CHF 6001Drug
CHF 6001 DPI single dose
| Study group | Role | What they receive |
|---|---|---|
| adolescent patients | Experimental | CHF 6001 dry powder inhaler (DPI) device, followed by a safety follow-up visit be done 12 to 14 days after the subject's study treatment administration. There is no comparator and all patients will receive the same study treatment. Receives: Drug: CHF 6001 |
| Adult patients | Experimental | CHF 6001 dry powder inhaler (DPI) device, followed by a safety follow-up visit be done 12 to 14 days after the subject's study treatment administration. There is no comparator and all patients will receive the same study treatment. Receives: Drug: CHF 6001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of CHF 6001 after oral inhalation of CHF 6001 Dry Powder Inhaler (DPI)
Measurements are performed to define the Pharmacokinetic (PK) profile after oral inhalation of CHF 6001 DPI in adolescent subjects with asthma in comparison to adult subjects with asthma.
Measured: Samples will be collected at the following time points: pre dose and post-dose at 30 minutes and 1, 2, 4, 8, 10, 24, 48, 72 and 96 hours
Area under the curve from 0 to the last quantifiable concentration (AUC 0-t) of CHF 6001 after oral inhalation of CHF 6001 DPI
Measurements are performed to define the PK profile after oral inhalation of CHF 6001 DPI in adolescent subjects with asthma in comparison to adult subjects with asthma.
Measured: Samples will be collected at the following time points: pre dose and post-dose at 30 minutes and 1, 2, 4, 8, 10, 24, 48, 72 and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start28 Mar 2025
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iva Popova, MD, Principal investigator, MC Comac Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900816
- Sponsor's protocol ID
- CLI-06001AC1-01
- Other IDs
- 2024-516483-29-00
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Single-dose, Open Label, Non-randomized, Parallel Group, Clinical Pharmacology Study of CHF 6001 in Asthmatic Adolescent Patients and in Asthmatic Adult Patients as Control Group
- ClinicalTrials.gov ID
- NCT06900816
- Acronym / sponsor ID
- CLI-06001AC1-01
- Conditions
- Asthma
- Keywords
- CHF6001, pharmacokinetics, adolescents, patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
Detailed description
The study plan foresees a total of four visits at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be trained to assess their ability to use an inhaler device and to teach the inhaling technique. At the following visit, the patients will inhale through the device and amount of the study drug and of its metabolites in the blood will be measured at different times after inhalation. At a subsequent ambulatory visit, the final measurements will be performed. A follow-up Visit will be done to check patients safety and wellbeing, 12 to 14 days after the study treatment intake. A total of 25 asthmatic adults (≥18 years), and 25 asthmatic adolescents ( ≥12 and <18 years) with a stable asthma therapy according to international guidelines Global Initiative for Asthma (GINA) (update 2024), will be enrolled.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescent patients | Experimental | Drug: CHF 6001CHF 6001 dry powder inhaler (DPI) device, followed by a safety follow-up visit be done 12 to 14 days after the subject's study treatment administration. There is no comparator and all patients will receive the same study treatment. |
| Adult patients | Experimental | Drug: CHF 6001CHF 6001 dry powder inhaler (DPI) device, followed by a safety follow-up visit be done 12 to 14 days after the subject's study treatment administration. There is no comparator and all patients will receive the same study treatment. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent: subject's and/or parents or legal representative (for adolescents) written informed consent obtained prior to any study-related procedures.
- Sex and age: a. Adolescent: male or female subjects aged ≥12 and <18 years; b. Adult: male or female subjects aged ≥18 and ≤75 years.
- Body weight for adolescents within the range of ≥34.7 kg for 12 years old and ≥40.4 kg for 13 to 17 years old.
- Body mass index for adults within the range of ≥18.0 to ≤30.0 kg/m2.
- Diagnosis of asthma: a documented history of physician diagnosed asthma according to international guidelines (GINA) update 2024 for ≥1 year, with diagnosis before the age of 50 years for adults.
Key exclusion criteria (23 listed)
- Blood donation (≥450 mL) or blood loss, less than 2 months before screening or before enrolment on Day 1, applicable for adults only.
- History of "at risk" asthma: history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the Investigator, may place the subject at undue risk.
- Recent exacerbation or respiratory tract infection: hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks before the screening visit. Note: Subjects experiencing an exacerbation or respiratory tract infection during the screening visit may be rescreened once, ≥6 weeks after recovery. If there is no recovery, such event constitutes an exclusion criterion and leads to screening failure.
- Subjects using systemic corticosteroid medication 4 weeks or slow release corticosteroids 12 weeks before enrolment.
- Patients being treated with anti-inflammatory asthma monoclonal antibodies or biological drugs which can affect asthma inflammation within 6 months before or five half-lives (whichever is greater) before the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF 6001CHF 6001 DPI single dose | Drug | adolescent patients |
| CHF 6001CHF 6001 DPI single dose | Drug | Adult patients |
Primary outcome
Maximum Plasma Concentration (Cmax) of CHF 6001 after oral inhalation of CHF 6001 Dry Powder Inhaler (DPI)
Time frame: Samples will be collected at the following time points: pre dose and post-dose at 30 minutes and 1, 2, 4, 8, 10, 24, 48, 72 and 96 hours
Measurements are performed to define the Pharmacokinetic (PK) profile after oral inhalation of CHF 6001 DPI in adolescent subjects with asthma in comparison to adult subjects with asthma.
Area under the curve from 0 to the last quantifiable concentration (AUC 0-t) of CHF 6001 after oral inhalation of CHF 6001 DPI
Time frame: Samples will be collected at the following time points: pre dose and post-dose at 30 minutes and 1, 2, 4, 8, 10, 24, 48, 72 and 96 hours
Measurements are performed to define the PK profile after oral inhalation of CHF 6001 DPI in adolescent subjects with asthma in comparison to adult subjects with asthma.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iva Popova, MD principal investigator
MC Comac Medical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 6001 in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of CHF 6001 after oral inhalation of CHF 6001 Dry Powder Inhaler (DPI) (time frame: Samples will be collected at the following time points: pre dose and post-dose at 30 minutes and 1, 2, 4, 8, 10, 24, 48, 72 and 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.