AsthmaPhase 1NCT03859414
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
A Phase 1 study testing Therapeutic Dose 1, Therapeutic Dose 2 and Supra-therapeutic Dose in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects under the same setting. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Therapeutic Dose 1, Therapeutic Dose 2 and Supra-therapeutic Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2019to 24 Jul 2019
- 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 20 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;
- Healthy male and female subjects aged 20 to 55 years inclusive;
- For Japanese subjects: must be a Japanese subject who has resided outside Japan for no more than 5 years, born in Japan and holding a Japanese passport, with all 4 grandparents Japanese, as confirmed by interview;
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol and to comply with the correct use of the devices specified in this protocol;
- Body mass index within the range of 18.0 to 25.0 kg/m2 inclusive;
- Non-smokers or ex-smokers who smoked <5 pack years and stopped smoking >1 year prior to screening;
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- Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12 -lead digitised Electrocardiogram (12-lead ECG);
- Vital signs (Blood pressure and body temperature) within normal limits;
- 12-lead ECG considered as normal;
- Lung function measurements within normal limits;
- Women of non-childbearing potential (WONCBP) and women of childbearing potential (WOCBP) fulfilling one of the following criteria: a) 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 visit or b) WOCBP with non-fertile male partners: (contraception is not required in this case).
- Female subject, except if postmenopausal, must have a negative serum beta-human chorionic gonadotropin at screening and a negative urine pregnancy test at Day -1 prior the first drug administration;
- Subjects must agree not to donate sperm or ova from the time of the first administration of study medication until three months after the end of the systemic exposure of the study drug or until the last follow-up visit, whichever occurs later;
- Males fulfilling one of the following criteria: a) Males with pregnant or non-pregnant WOCBP partners: they must be willing to use male condom from the signature of the informed consent and until the follow-up visit or b) Non-fertile male subjects (contraception is not required in this case) or c) Males with partner not of childbearing potential (contraception is not required in this case).
Who cannot join
- Participation in another clinical trial with an investigational drug in the 90 days or 5 half-lives of non-biological entities of that investigational drug (whichever is longer) preceding the administration of the study drug;
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this study;
- Any other abnormal findings on vital signs, ECG, physical examination or laboratory evaluation of blood and urine samples that the investigator judges as likely to interfere with the study or pose an additional risk in participating;
- Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic;
- History of asthma, including childhood asthma, Chronic Obstructive Pulmonary Disease (COPD) or any other chronic pulmonary diseases or condition;
- Positive HIV1 or HIV2 serology;
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- results from the Hepatitis serology at screening which indicates acute or chronic Hepatitis (i.e. positive HB surface antigen (HBsAg), HB core antibody (anti-HBc), or Hepatitis C (positive HCV antibody);
- Blood donation or blood loss (equal or more than 450 mL), less than 2 months prior to randomisation;
- Abnormal haemoglobin level defined as <12.0 g/dL in females and <14.0 g/dL in males;
- Positive urine test for cotinine at screening or prior to randomisation;
- Unsuitable veins for repeated venepuncture;
- History or clinical evidence of drug and/or alcohol abuse within 12 months prior to screening and randomisation;
- Known intolerance/hypersensitivity to any of the excipients/components contained in any of the formulations used in the trial;
- Taking any drug treatment, including prescribed or Over the Counter (OTC) medicines as well as homeopathic remedies etc., in the 14 days before the screening and prior randomisation, with the exception of occasional paracetamol (maximum 3 g per day with a maximum of 10 g per 14 days for mild non-exclusionary conditions), hormonal contraceptives; hormonal replacement treatment for post-menopausal women, occasional ibuprofen (maximum 1.2 g per day, not to exceed 12 g in the 14 days before the screening);
- 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 or prior to randomisation;
- Heavy caffeine drinker >28 cups/week of coffee or similar caffeinated beverages e.g., tea, cola per day);
- Bacterial or viral respiratory tract, sinus or middle ear infection affecting health status within 4 weeks prior to randomisation;
- Night shift workers with night shifts within 8 weeks prior to randomisation and during the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology Ltd
London, Tooting, SW17 0RE
About this study
Official title: A Single-center, Randomized, Double-blind, Single Dose, 4-way Cross-over, Placebo-controlled Ethnic Sensitivity Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Tolerability of Different Dosages of CHF 5993 Pressurized Metered Dose Inhaler (pMDI) in Caucasian and Japanese Healthy Subjects
The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects under the same setting.
Read the detailed description
The Study is single-centre, randomized, double-blind, single-dose, 4-way cross-over, placebo-controlled.
The safety, tolerability, PD and PK of CHF 5993 will be assessed in Japanese and Caucasian healthy volunteers.
A total of 32 healthy male and female volunteers are planned to be included where they will receive four different treatments (study drug or placebo) over four treatment periods.
Standard safety assessments will be conducted during the study, including safety blood and urine laboratory tests, liver function tests, vital signs, physical examinations, ECGs, 24-hour Holter and observations of any adverse events. Blood samples will also be collected for PK analysis. Blood and urine samples will be collected for pharmacodynamics analysis.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Therapeutic Dose 1, Therapeutic Dose 2, Supra-therapeutic Dose, Placebo
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Dose 1Drug
CHF 5993 100/6/12.5 µg pMDI, fixed combination of BDP 100 µg + FF 6 µg + GB 12.5 µg.
Therapeutic Dose 2Drug
CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.
Supra-therapeutic DoseDrug
CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.
PlaceboDrug
CHF 5993 placebo pMDI
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Dose 1 | Active comparator | Single dose administration of CHF 5993 100/6/12.5 µg pMDI 2 inhalations. Total dose of CHF 5993 pMDI = 200/12/25 µg Receives: Drug: Therapeutic Dose 1 |
| Therapeutic Dose 2 | Active comparator | Single dose administration of CHF 5993 200/6/12.5 µg pMDI 2 inhalations. Total dose of CHF 5993 pMDI = 400/12/25 µg Receives: Drug: Therapeutic Dose 2 |
| Supra-therapeutic Dose | Active comparator | Single dose administration of CHF 5993 100/6/12.5 µg pMDI 8 inhalations Total dose of CHF 5993 pMDI = 800/48/100 µg Receives: Drug: Supra-therapeutic Dose |
| Placebo | Placebo comparator | Single dose administration of CHF 5993 pMDI placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of B17MP, formoterol and GB
Area under the plasma concentration versus time curve after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration for B17MP and FF, over 48 hours after administration for GB
Maximum of Concentration (Cmax) of B17MP, FF and GB
Peak Plasma Concentration after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration for B17MP and FF, over 48 hours after administration for GB
Secondary outcomes (8)
Number of Adverse Events (AEs)
Assessment of the general safety and tolerability in terms of number of Treatment Emergent Adverse Event (TEAEs), Adverse Drug Reaction (ADRs), serious TEAEs, severe TEAEs and TEAEs leading to study discontinuation and to death.
Measured: through study completion, an average of 13 weeks
Number of subjects with Adverse Events
Assessment of the general safety and tolerability in terms number of subjects with TEAEs, ADRs, serious TEAEs, severe TEAEs and TEAEs leading to study discontinuation and to death.
Measured: through study completion, an average of 13 weeks
Percentage of subjects with Adverse Events
Assessment of the general safety and tolerability in terms of incidence of TEAEs, ADRs, serious TEAEs, severe TEAEs and TEAEs leading to study discontinuation and to death.
Measured: through study completion, an average of 13 weeks
Clinical laboratory parameters (biochemistry)
Assessment of PD profile in terms of plasma cortisol, serum potassium and serum glucose after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration
Clinical laboratory parameters (urinalysis)
Assessment of PD profile in terms of urine cortisol and creatinine excretion after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration
Heart rate
Assessment of PD profile in terms of the Heart Rate after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration
12-lead ECG parameters
Assessment of pharmacodynamics profile in terms of 12-lead ECG parameters extracted from Holter after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration
Vital signs
Assessment of pharmacodynamics profile in terms of vital signs (systolic and diastolic blood pressure) after a single-dose administration of CHF 5993 pMDI
Measured: Over 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start18 Mar 2019
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-way Crossover Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT03859414
- Sponsor's protocol ID
- CLI-05993AB4-01
- Other IDs
- 2018-003310-40, 2018
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cella M, Taubel J, Delestre-Levai I, Tulard A, Vele A, Georges G. Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover Study. Clin Ther. 2021 Nov;43(11):1934-1947.e4. doi: 10.1016/j.clinthera.2021.09.001. Epub 2021 Sep 29.
PubMed 34600734
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Single Dose, 4-way Cross-over, Placebo-controlled Ethnic Sensitivity Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Tolerability of Different Dosages of CHF 5993 Pressurized Metered Dose Inhaler (pMDI) in Caucasian and Japanese Healthy Subjects
- ClinicalTrials.gov ID
- NCT03859414
- Acronym / sponsor ID
- CLI-05993AB4-01
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 1 Mar 2019 (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 conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects under the same setting.
Detailed description
The Study is single-centre, randomized, double-blind, single-dose, 4-way cross-over, placebo-controlled.
The safety, tolerability, PD and PK of CHF 5993 will be assessed in Japanese and Caucasian healthy volunteers.
A total of 32 healthy male and female volunteers are planned to be included where they will receive four different treatments (study drug or placebo) over four treatment periods.
Standard safety assessments will be conducted during the study, including safety blood and urine laboratory tests, liver function tests, vital signs, physical examinations, ECGs, 24-hour Holter and observations of any adverse events. Blood samples will also be collected for PK analysis. Blood and urine samples will be collected for pharmacodynamics analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4-way Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Dose 1 | Active comparator | Drug: Therapeutic Dose 1Single dose administration of CHF 5993 100/6/12.5 µg pMDI 2 inhalations. Total dose of CHF 5993 pMDI = 200/12/25 µg |
| Therapeutic Dose 2 | Active comparator | Drug: Therapeutic Dose 2Single dose administration of CHF 5993 200/6/12.5 µg pMDI 2 inhalations. Total dose of CHF 5993 pMDI = 400/12/25 µg |
| Supra-therapeutic Dose | Active comparator | Drug: Supra-therapeutic DoseSingle dose administration of CHF 5993 100/6/12.5 µg pMDI 8 inhalations Total dose of CHF 5993 pMDI = 800/48/100 µg |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose administration of CHF 5993 pMDI placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subject's written informed consent obtained prior to any study related procedure;
- Healthy male and female subjects aged 20 to 55 years inclusive;
- For Japanese subjects: must be a Japanese subject who has resided outside Japan for no more than 5 years, born in Japan and holding a Japanese passport, with all 4 grandparents Japanese, as confirmed by interview;
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol and to comply with the correct use of the devices specified in this protocol;
- Body mass index within the range of 18.0 to 25.0 kg/m2 inclusive;
Key exclusion criteria (18 listed)
- Participation in another clinical trial with an investigational drug in the 90 days or 5 half-lives of non-biological entities of that investigational drug (whichever is longer) preceding the administration of the study drug;
- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this study;
- Any other abnormal findings on vital signs, ECG, physical examination or laboratory evaluation of blood and urine samples that the investigator judges as likely to interfere with the study or pose an additional risk in participating;
- Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic;
- History of asthma, including childhood asthma, Chronic Obstructive Pulmonary Disease (COPD) or any other chronic pulmonary diseases or condition;
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 |
|---|---|---|
| Therapeutic Dose 1CHF 5993 100/6/12.5 µg pMDI, fixed combination of BDP 100 µg + FF 6 µg + GB 12.5 µg. | Drug | Therapeutic Dose 1 |
| Therapeutic Dose 2CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg. | Drug | Therapeutic Dose 2 |
| Supra-therapeutic DoseCHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg. | Drug | Supra-therapeutic Dose |
| PlaceboCHF 5993 placebo pMDI | Drug | Placebo |
Primary outcome
Area Under the Curve (AUC) of B17MP, formoterol and GB
Time frame: Over 24 hours after administration for B17MP and FF, over 48 hours after administration for GB
Area under the plasma concentration versus time curve after a single-dose administration of CHF 5993 pMDI
Maximum of Concentration (Cmax) of B17MP, FF and GB
Time frame: Over 24 hours after administration for B17MP and FF, over 48 hours after administration for GB
Peak Plasma Concentration after a single-dose administration of CHF 5993 pMDI
8 secondary outcomes
Number of Adverse Events (AEs)
Time frame: through study completion, an average of 13 weeks
Number of subjects with Adverse Events
Time frame: through study completion, an average of 13 weeks
Percentage of subjects with Adverse Events
Time frame: through study completion, an average of 13 weeks
Clinical laboratory parameters (biochemistry)
Time frame: Over 24 hours after administration
Clinical laboratory parameters (urinalysis)
Time frame: Over 24 hours after administration
Heart rate
Time frame: Over 24 hours after administration
12-lead ECG parameters
Time frame: Over 24 hours after administration
Vital signs
Time frame: Over 24 hours 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 22 Oct 2021.
- Results publication: PubMed 34600734Cella M, Taubel J, Delestre-Levai I, Tulard A, Vele A, Georges G. Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover Study. Clin Ther. 2021 Nov;43(11):1934-1947.e4. doi: 10.1016/j.clinthera.2021.09.001. Epub 2021 Sep 29.
- 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 Therapeutic Dose 1, Therapeutic Dose 2 and Supra-therapeutic Dose in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
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 14 inclusion and 18 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 22 Oct 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 United Kingdom. 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?
Area Under the Curve (AUC) of B17MP, formoterol and GB (time frame: Over 24 hours after administration for B17MP and FF, over 48 hours after administration for GB). 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?
On the ClinicalTrials.gov record for NCT03859414, which also lists 1 linked publication.
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 22 Oct 2021.