Foster With or Without Charcoal Block or Aerochamber Plus

This study has been completed.
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01280175
First received: January 17, 2011
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Healthy Volunteers.
Procedure: charcoal block
Device: Aerochamber Plus spacer
Drug: pMDI standard actuator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Systemic exposure and lung bioavailability of BDP, B17MP and formoterol. [ Time Frame: from pre-dose until 12 h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General tolerability and safety of the test product. [ Time Frame: from pre-dose until 12 h post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: December 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pMDI + charcoal block
BDP/formoterol 100/6 µg pMDI with charcoal ingestion
Procedure: charcoal block
Experimental: pMDI + Aerochamber Plus
BDP/formoterol 100/6 µg with Aerochamber Plus
Device: Aerochamber Plus spacer
Active Comparator: pMDI
BDP/formoterol 100/g µg pMDI
Drug: pMDI standard actuator

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280175

Locations
Switzerland
CROSS Research SA
Arzo, via F.A. Giorgioli, 14, Switzerland, 6864
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Cross Research S.A.
Investigators
Principal Investigator: Antonio Rusca, MD, FMH CROSS Research SA
  More Information

No publications provided

Responsible Party: Sara Collarini / Clinical Study Manager, Chiesi Farmaceutici
ClinicalTrials.gov Identifier: NCT01280175     History of Changes
Other Study ID Numbers: FB/PS/14/163/06
Study First Received: January 17, 2011
Last Updated: January 19, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Chiesi Farmaceutici S.p.A.:
BDP
Formoterol
pMDI
Aerochamber Plus
Charcoal

Additional relevant MeSH terms:
Charcoal
Formoterol
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014