CompletedPhase 1

Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers

Belgium50 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).

Exclusion criteria

. Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks prior screening or prior randomization.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 72 hours after adminstration

Trial details

NCT IDNCT02743013

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07

View on ClinicalTrials.gov More COPD trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).

Exclusion criteria

. Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks prior screening or prior randomization.

What they're measuring

Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 72 hours after adminstration