AsthmaPhase 1NCT02359292
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers
A Phase 1 study testing CHF 5993 HS 200/6/25 pMDI, CHF 5993 MS 100/6/25 pMDI and CHF 5993 HS 200/6/25 pMDI + Charcoal Block in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- CHF 5993 HS 200/6/25 pMDI, CHF 5993 MS 100/6/25 pMDI and CHF 5993 HS 200/6/25 pMDI + Charcoal Block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jul 2015
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's written informed consent obtained prior to any study related procedure.
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Male and female subjects aged 18 to 55 years inclusive.
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
- Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day, times the number of years) and stopped smoking > 1 year prior to screening.
- Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and before randomization.
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- Lung function measurements within normal limits (Normal values (according to GINA 2014 document): FEV1/FVC > 0.70 and FEV1 > 80% predicted).
- Male subjects: they and/or their partner must be willing to use an approved method of contraception from the time of screening and until 30 days after the last dose of study. Subjects must not donate sperm for 30 days after the last dose of study drug.*
- Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant), using an acceptable method of contraception
- Surgical sterilization (i.e. bilateral tubal ligation, hysterectomy for females; vasectomy for males)
- Hormonal contraception (implantable, injectable, patch, oral)
- Double-barrier methods: condom and occlusive cap (diaphragm or cervical/vault caps)
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Who cannot join
- Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks before inhalation of the study medication.
- Female subjects: pregnant or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of the gestation) confirmed by a positive urine test at screening and randomization.
- Positive HIV1 or HIV2 serology.
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C.
- Unsuitable veins for repeated venipuncture.
- History of alcohol abuse within 12 months prior to screening.
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- History of drug abuse within 12 months prior to screening (or positive urine drug test performed at screening).
- Subjects who have a positive urine test for cotinine.
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation. Note: In case of abnormal laboratory values, the test can be performed again once before randomization.
- Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
- History of glaucoma, symptomatic prostatism or urinary retention.
- Subjects who have cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained means lasting more than 30 seconds and or ending only with external action, and or leads to hemodynamic collapse; non-sustained means > 3 beats < 30 seconds, and or ending spontaneously, and or asymptomatic), impulse conduction high degree blocks, ICD implant
- Abnormal ECG (i.e.: QRS > 120 msec, PR > 220 msec, HR < 40 bpm, HR > 110 bpm, QTcF > 450 ms for males or QTcF > 470 ms for females) at screening.
- Note: In case of abnormal ECG, the test can be performed again once before randomization.
- Clinically significant abnormal 24h-Holter monitoring at screening (if necessary the Holter evaluation can be done on another day before randomization).
- Abnormal Blood Pressure (Average Diastolic Blood Pressure > 90 mmHg or average Systolic Blood Pressure > 140 mmHg) at screening.
- Note: In case of abnormal blood pressure, measure can be done again once before randomization.
- Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening.
- History of hypersensitivity to any of the excipients contained in the formulations used in the trial.
- Subject taking any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days before the screening with the exception of :
- Occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions);
- Hormonal contraceptives;
- Hormonal replacement treatment for post-menopausal women.
- Subject taking treatment, with enzyme-inducing or enzyme-inhibiting drugs and biologic drugs and with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole), taken since 3 months before screening until randomization.
- Heavy caffeine drinker (> 5 caffeinated beverages e.g., coffee, tea, cola per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over Clinical Pharmacology Study, to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination Across Two Different Dose Strengths, Administered With and Without Activated Charcoal, in Healthy Volunteers
The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.
- Conditions
- Asthma
- Being tested
- CHF 5993 HS 200/6/25 pMDI, CHF 5993 MS 100/6/25 pMDI, CHF 5993 HS 200/6/25 pMDI + Charcoal Block, CHF 5993 MS 100/6/25 pMDI + Charcoal Block, Placebo pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 5993 HS 200/6/25 pMDIDrug
CHF 5993 MS 100/6/25 pMDIDrug
CHF 5993 HS 200/6/25 pMDI + Charcoal BlockDrug
CHF 5993 MS 100/6/25 pMDI + Charcoal BlockDrug
Placebo pMDIDrug
| Study group | Role | What they receive |
|---|---|---|
| CHF 5993 HS 200/6/25 pMDI | Experimental | High Strength fixed combination Receives: Drug: CHF 5993 HS 200/6/25 pMDI |
| CHF 5993 MS 100/6/25 pMDI | Active comparator | Medium Strength fixed combination Receives: Drug: CHF 5993 MS 100/6/25 pMDI |
| CHF 5993 HS 200/6/25 pMDI + Charcoal Block | Experimental | High Strength fixed combination plus Charcoal Block Receives: Drug: CHF 5993 HS 200/6/25 pMDI + Charcoal Block |
| CHF 5993 MS 100/6/25 pMDI + Charcoal Block | Active comparator | Medium Strength fixed combination plus Charcoal Block Receives: Drug: CHF 5993 MS 100/6/25 pMDI + Charcoal Block |
| Placebo pMDI | Placebo comparator | Placebo Receives: Drug: Placebo pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables
Composite outcome measures of PK variables
Measured: over 32hours after administration
Lung exposure of B17MP, Formoterol and Glycopyrronium bromide without charcoal block (To evaluate the lung exposure (as AUCt and Cmax) Composite outcome measures of PK variables
Composite outcome measures of PK variables
Measured: over 32hours after administration
Secondary outcomes (2)
Systemic effects of CHF5993 (To evaluate the systemic effects as potassium and glucose levels) Composite outcome measures of PD variables
Composite outcome measures of PD variables
Measured: over 24hours after administration
Systemic cardiac effects and the general safety (Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE)
Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE)
Measured: over 24hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionJul 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359292
- Sponsor's protocol ID
- CCD-05993AB2-01
- Status last verified
- Jun 2021
- First submitted
- 30 Jan 2015
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Clinical Pharmacology Study, to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination Across Two Different Dose Strengths, Administered With and Without Activated Charcoal, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02359292
- Acronym / sponsor ID
- CCD-05993AB2-01
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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 study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHF 5993 HS 200/6/25 pMDI | Experimental | Drug: CHF 5993 HS 200/6/25 pMDIHigh Strength fixed combination |
| CHF 5993 MS 100/6/25 pMDI | Active comparator | Drug: CHF 5993 MS 100/6/25 pMDIMedium Strength fixed combination |
| CHF 5993 HS 200/6/25 pMDI + Charcoal Block | Experimental | Drug: CHF 5993 HS 200/6/25 pMDI + Charcoal BlockHigh Strength fixed combination plus Charcoal Block |
| CHF 5993 MS 100/6/25 pMDI + Charcoal Block | Active comparator | Drug: CHF 5993 MS 100/6/25 pMDI + Charcoal BlockMedium Strength fixed combination plus Charcoal Block |
| Placebo pMDI | Placebo comparator | Drug: Placebo pMDIPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject's written informed consent obtained prior to any study related procedure.
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Male and female subjects aged 18 to 55 years inclusive.
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
- Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day, times the number of years) and stopped smoking > 1 year prior to screening.
Key exclusion criteria (25 listed)
- Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks before inhalation of the study medication.
- Female subjects: pregnant or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of the gestation) confirmed by a positive urine test at screening and randomization.
- Positive HIV1 or HIV2 serology.
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C.
- Unsuitable veins for repeated venipuncture.
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 5993 HS 200/6/25 pMDI | Drug | CHF 5993 HS 200/6/25 pMDI |
| CHF 5993 MS 100/6/25 pMDI | Drug | CHF 5993 MS 100/6/25 pMDI |
| CHF 5993 HS 200/6/25 pMDI + Charcoal Block | Drug | CHF 5993 HS 200/6/25 pMDI + Charcoal Block |
| CHF 5993 MS 100/6/25 pMDI + Charcoal Block | Drug | CHF 5993 MS 100/6/25 pMDI + Charcoal Block |
| Placebo pMDI | Drug | Placebo pMDI |
Primary outcome
Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables
Time frame: over 32hours after administration
Composite outcome measures of PK variables
Lung exposure of B17MP, Formoterol and Glycopyrronium bromide without charcoal block (To evaluate the lung exposure (as AUCt and Cmax) Composite outcome measures of PK variables
Time frame: over 32hours after administration
Composite outcome measures of PK variables
2 secondary outcomes
Systemic effects of CHF5993 (To evaluate the systemic effects as potassium and glucose levels) Composite outcome measures of PD variables
Time frame: over 24hours after administration
Systemic cardiac effects and the general safety (Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE)
Time frame: over 24hours after administration
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 2 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHF 5993 HS 200/6/25 pMDI, CHF 5993 MS 100/6/25 pMDI and CHF 5993 HS 200/6/25 pMDI + Charcoal Block in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
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 13 inclusion and 25 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 2 Jul 2021. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables (time frame: over 32hours after administration). 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 2 Jul 2021.