COPDPhase 1NCT02743013
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
A Phase 1 study testing CHF 5993 100/6/12,5 pMDI, CHF 5993 100/6/12,5 DPI Test 1 and CHF 5993 100/6/12,5 DPI Test 2 in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- CHF 5993 100/6/12,5 pMDI, CHF 5993 100/6/12,5 DPI Test 1 and CHF 5993 100/6/12,5 DPI Test 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Jul 2016
- 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.
- Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
- Ability to generate sufficient PIF (at least 40 L/min) using the In-Check device simulating NEXThaler® device.
- Male and female Caucasian subjects aged 18 to 55 years inclusive.
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
- Non-smokers 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.
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- Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and before randomization.
- Lung function measurements within normal limits (Normal values: FEV1/FVC is > 0.70 and FEV1 > 80% predicted).
- Female subject of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female subjects of childbearing potential (WOCBP) fulfilling one of the following criteria:
- WOCBP with fertile male partners: they and/or their partner of childbearing potential must be willing to use a double barrier contraceptive method including one highly effective birth control method and one acceptable birth control method (male or female condom with or without spermicide and/or cap, diaphragm or sponge with spermicide), from the signature of the informed consent and until 3 months after follow-up visit;
- WOCBP with non-fertile male partners: contraception is not required in this case.
Who cannot join
- Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks prior screening or prior randomization.
- Abnormal haemoglobin level defined as < 10.5 g/dl
- For females only: pregnant and lactating female subjects, confirmed by a positive serum test at screening and/or urine test before 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.
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- Documented history of alcohol abuse within 12 months prior to screening.
- Documented history of drug abuse within 12 months prior to screening, or positive urine drug test performed at screening and/or before randomization.
- Subjects who have a positive urine test for cotinine at screening and/or before randomization.
- Clinically relevant abnormal laboratory values, suggesting an unknown disease and requiring further clinical investigation.
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
- Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
- Subjects with history of asthma, including childhood asthma.
- Known intolerance/ hypersensitivity to any of the excipients contained in any of the formulations used in the trial.
- Abnormal 12-lead digitized Electrocardiogram (12-lead ECG) parameter (i.e.: QRS > 120 msec and/or PR > 220 msec and/or HR < 40 bpm and/or HR > 110 bpm and/or QTcF > 450 ms for males or QTcF > 470 ms for female, considering the average from triplicate) or 12-lead ECG evaluated as abnormal clinical significant by the investigator, at screening.
- Abnormal Blood Pressure (i.e.: Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg, considering the average from triplicate) at screening.
- Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening.
- Subject taking any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, 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 enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening.
- Heavy caffeine drinker (> 5 caffeinated beverages e.g., coffee, tea, cola per day).
- Subject who has had a lower respiratory tract infection within 4 weeks prior to screening or prior randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993, Administered Via the Multi-dose Reservoir NEXThaler® Dry Powder Inhaler and Via a HFA-pressurised Metered Dose Inhaler With and Without Valved Holding Chamber, in Healthy Volunteers
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
- Conditions
- COPD
- Being tested
- CHF 5993 100/6/12,5 pMDI, CHF 5993 100/6/12,5 DPI Test 1, CHF 5993 100/6/12,5 DPI Test 2, CHF 5993 100/6/12,5 pMDI replicate, CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 5993 100/6/12,5 pMDIDrug
CHF 5993 100/6/12,5 DPI Test 1Drug
CHF 5993 100/6/12,5 DPI Test 2Drug
CHF 5993 100/6/12,5 pMDI replicateDrug
CHF 5993 100/6/12,5 pMDI with Valved Holding ChamberDrug
| Study group | Role | What they receive |
|---|---|---|
| CHF 5993 100/6/12,5 pMDI | Active comparator | with/without Charcoal Block Receives: Drug: CHF 5993 100/6/12,5 pMDI |
| CHF 5993 100/6/12,5 pMDI (replicate) | Active comparator | with/without Charcoal Block Receives: Drug: CHF 5993 100/6/12,5 pMDI replicate |
| CHF 5993 100/6/12,5 pMDI VHC | Active comparator | with/without Charcoal Block with Valved Holding Chamber Receives: Drug: CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber |
| CHF 5993 100/6/12,5 DPI test 1 | Experimental | with/without Charcoal Block Receives: Drug: CHF 5993 100/6/12,5 DPI Test 1 |
| CHF 5993 100/6/12,5 DPI test 2 | Experimental | with/without Charcoal Block Receives: Drug: CHF 5993 100/6/12,5 DPI Test 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
AUC0-t
Measured: 72 hours after adminstration
Evaluation of the Area under the curve (AUC) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
AUC 0-t
Measured: 72 hours after adminstration
Evaluation of the Maximum Plasma Concentration (Cmax) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
Cmax
Measured: 72 hours after adminstration
Evaluation of the Maximum Plasma Concentration (Cmax) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
Cmax
Measured: 72 hours after adminstration
Secondary outcomes (5)
Evaluate the Area Under the Curve of Beclometasone Dipropionate, B17MP (active metabolite of Beclometasone Dipropionate), formoterol and Glycopirronium bromide with and without charcoal blockage
Area Under the Curve
Measured: 72 hours after adminstration
Evaluate the Maximum Plasma Concentration of Beclometasone Dipropionate, B17MP (active metabolite of Beclometasone Dipropionate), formoterol and Glycopirronium bromide with and without charcoal blockage
Maximum Plasma concentration
Measured: 72 hours after adminstration
Evaluate the number of Adverse events and adverse drug reactions
Measured: 72 hours after adminstration
Evaluation of Blood pressure
Measurement of Blood pressure
Measured: 72 hours after adminstration
Evaluation of the heart rate
Measurement of Heart rate
Measured: 72 hours after adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- NCT02743013
- Sponsor's protocol ID
- CCD-05993BA1-01
- Other IDs
- 2015-005198-19, 2015
- Status last verified
- Jun 2021
- First submitted
- 31 Mar 2016
- 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
- Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993, Administered Via the Multi-dose Reservoir NEXThaler® Dry Powder Inhaler and Via a HFA-pressurised Metered Dose Inhaler With and Without Valved Holding Chamber, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02743013
- Acronym / sponsor ID
- CCD-05993BA1-01
- Conditions
- COPD
- 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
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Apr 2016 (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.
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHF 5993 100/6/12,5 pMDI | Active comparator | Drug: CHF 5993 100/6/12,5 pMDIwith/without Charcoal Block |
| CHF 5993 100/6/12,5 pMDI (replicate) | Active comparator | Drug: CHF 5993 100/6/12,5 pMDI replicatewith/without Charcoal Block |
| CHF 5993 100/6/12,5 pMDI VHC | Active comparator | Drug: CHF 5993 100/6/12,5 pMDI with Valved Holding Chamberwith/without Charcoal Block with Valved Holding Chamber |
| CHF 5993 100/6/12,5 DPI test 1 | Experimental | Drug: CHF 5993 100/6/12,5 DPI Test 1with/without Charcoal Block |
| CHF 5993 100/6/12,5 DPI test 2 | Experimental | Drug: CHF 5993 100/6/12,5 DPI Test 2with/without Charcoal Block |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject's written informed consent obtained prior to any study related procedure.
- Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
- Ability to generate sufficient PIF (at least 40 L/min) using the In-Check device simulating NEXThaler® device.
- Male and female Caucasian subjects aged 18 to 55 years inclusive.
- Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
Key exclusion criteria (24 listed)
- Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks prior screening or prior randomization.
- Abnormal haemoglobin level defined as < 10.5 g/dl
- For females only: pregnant and lactating female subjects, confirmed by a positive serum test at screening and/or urine test before randomization.
- Positive HIV1 or HIV2 serology.
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C.
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 100/6/12,5 pMDI | Drug | CHF 5993 100/6/12,5 pMDI |
| CHF 5993 100/6/12,5 DPI Test 1 | Drug | CHF 5993 100/6/12,5 DPI test 1 |
| CHF 5993 100/6/12,5 DPI Test 2 | Drug | CHF 5993 100/6/12,5 DPI test 2 |
| CHF 5993 100/6/12,5 pMDI replicate | Drug | CHF 5993 100/6/12,5 pMDI (replicate) |
| CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber | Drug | CHF 5993 100/6/12,5 pMDI VHC |
Primary outcome
Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
Time frame: 72 hours after adminstration
AUC0-t
Evaluation of the Area under the curve (AUC) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
Time frame: 72 hours after adminstration
AUC 0-t
Evaluation of the Maximum Plasma Concentration (Cmax) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
Time frame: 72 hours after adminstration
Cmax
Evaluation of the Maximum Plasma Concentration (Cmax) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
Time frame: 72 hours after adminstration
Cmax
5 secondary outcomes
Evaluate the Area Under the Curve of Beclometasone Dipropionate, B17MP (active metabolite of Beclometasone Dipropionate), formoterol and Glycopirronium bromide with and without charcoal blockage
Time frame: 72 hours after adminstration
Evaluate the Maximum Plasma Concentration of Beclometasone Dipropionate, B17MP (active metabolite of Beclometasone Dipropionate), formoterol and Glycopirronium bromide with and without charcoal blockage
Time frame: 72 hours after adminstration
Evaluate the number of Adverse events and adverse drug reactions
Time frame: 72 hours after adminstration
Evaluation of Blood pressure
Time frame: 72 hours after adminstration
Evaluation of the heart rate
Time frame: 72 hours after adminstration
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 100/6/12,5 pMDI, CHF 5993 100/6/12,5 DPI Test 1 and CHF 5993 100/6/12,5 DPI Test 2 in people with COPD, 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 11 inclusion and 24 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. 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?
Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide. (time frame: 72 hours after adminstration). The study lists 4 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.