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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

Page last updated: August 20, 2015

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