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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014