Foster With or Without Charcoal Block or Aerochamber Plus
Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers.
Intervention: charcoal block (Procedure); Aerochamber Plus spacer (Device); pMDI standard actuator (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chiesi Farmaceutici S.p.A. Official(s) and/or principal investigator(s): Antonio Rusca, MD, FMH, Principal Investigator, Affiliation: CROSS Research SA
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
Secondary outcome: General tolerability and safety of the test product.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
CROSS Research SA, Arzo, via F.A. Giorgioli, 14 6864, Switzerland
Additional Information
Starting date: December 2006
Last updated: January 19, 2011
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