Clinical trial NCT01280175: Foster With or Without Charcoal Block or Aerochamber Plus
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BDP
Formoterol
pMDI
Aerochamber Plus
Charcoal
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Cross Research S.A.
First posted: 2011-01-20
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
timeFrame: from pre-dose until 12 h post-dose
Secondary outcomes:
measure: General tolerability and safety of the test product.
timeFrame: from pre-dose until 12 h post-dose
Other outcomes:
Locations:
city: Arzo
country: Switzerland
facility: CROSS Research SA
state: Via F.A. Giorgioli, 14
Study officials:
affiliation: CROSS Research SA
name: Antonio Rusca, MD, FMH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh D, Collarini S, Poli G, Acerbi D, Amadasi A, Rusca A. Effect of AeroChamber Plus on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI. Br J Clin Pharmacol. 2011 Dec;72(6):932-9. doi: 10.1111/j.1365-2125.2011.04024.x.