Foster With or Without Charcoal Block or Aerochamber Plus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator

Official Title
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Pharmacokinetics and Lung Bioavailability of BDP/Formoterol HFA Fixed Combination After Single Administration in 12 Healthy Volunteers Using the Standard Actuator With or Without Charcoal Block or the Aerochamber Spacer.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Procedure: charcoal block
* Device: Aerochamber Plus spacer
* Drug: pMDI standard actuator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: male 18≤age≤45 years old BMI: 18≤BMI≤28 kg/m2 Non-smokers Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm, measured after 5 min of rest in the sitting position Full comprehension: ability to use correctly the pMDI preparations; ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study Informed Consent: signed written informed consent prior to inclusion in the study. Exclusion Criteria: ECG (12 leads): clinically relevant abnormalities and/or QTc >450 msec; Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study; in particular any abnormality in the lung functionality: FEV1 <80% predicted values according to European Respiratory Society basing upon Quanjer et al. (25) Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; in particular positive HIV1 and HIV2 serology and/or positive hepatitis serology indicating acute or chronic hepatitis B or C Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study Medications: medication, including OTC, during 2 weeks before the start of the study. Any known enzyme inducing drug or enzyme inhibitor must be stopped at least 2 months before study start Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the screening Blood donation: blood donations during the 3 months prior to this study Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to USDA Dietary Guidelines 2005 (26)], caffeine (>5 cups coffee/tea/day) abuse or smoking Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pMDI + charcoal block<br>BDP/formoterol 100/6 µg pMDI with charcoal ingestion | Procedure: charcoal block<br> <br> |
| Experimental: pMDI + Aerochamber Plus<br>BDP/formoterol 100/6 µg with Aerochamber Plus | Device: Aerochamber Plus spacer<br> <br> |
| Active Comparator: pMDI<br>BDP/formoterol 100/g µg pMDI | Drug: pMDI standard actuator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure and lung bioavailability of BDP, B17MP and formoterol. |  | from pre-dose until 12 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerability and safety of the test product. |  | from pre-dose until 12 h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BDP, Formoterol, pMDI, Aerochamber Plus, Charcoal