Foster With or Without Charcoal Block or Aerochamber Plus

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280175
• Other study ID #: FB/PS/14/163/06
• Status: Completed
• Phase: Phase 1
• Start date: December 2006
• Est. completion date: February 2007

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• charcoal block

Device:
• Aerochamber Plus spacer

Drug:
• pMDI standard actuator

Locations

Country	Name	City	State
Switzerland	CROSS Research SA	Arzo	Via F.A. Giorgioli, 14

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.	Cross Research S.A.

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.		from pre-dose until 12 h post-dose
Secondary	General tolerability and safety of the test product.		from pre-dose until 12 h post-dose