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Foster With or Without Charcoal Block or Aerochamber Plus

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ClinicalTrials.gov Identifier: NCT01280175
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by:
Chiesi Farmaceutici S.p.A.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Procedure: charcoal block Device: Aerochamber Plus spacer Drug: pMDI standard actuator Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : December 2006
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Systemic exposure and lung bioavailability of BDP, B17MP and formoterol. [ Time Frame: from pre-dose until 12 h post-dose ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

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

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