Foster With or Without Charcoal Block or Aerochamber Plus

Chiesi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Procedure: charcoal block; Device: Aerochamber Plus spacer; Drug: pMDI standard actuator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01280175

FB/PS/14/163/06

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

pMDI + charcoal block

Experimental group

Description:

BDP/formoterol 100/6 µg pMDI with charcoal ingestion

Treatment:

Procedure: charcoal block

pMDI + Aerochamber Plus

Experimental group

Description:

BDP/formoterol 100/6 µg with Aerochamber Plus

Treatment:

Device: Aerochamber Plus spacer

pMDI

Active Comparator group

Description:

BDP/formoterol 100/g µg pMDI

Treatment:

Drug: pMDI standard actuator