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

January 17, 2011
January 19, 2011
December 2006
February 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01280175 on ClinicalTrials.gov Archive Site
General tolerability and safety of the test product. [ Time Frame: from pre-dose until 12 h post-dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Foster With or Without Charcoal Block or Aerochamber Plus
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.

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers.
  • Procedure: charcoal block
  • Device: Aerochamber Plus spacer
  • Drug: pMDI standard actuator
  • Experimental: pMDI + charcoal block
    BDP/formoterol 100/6 µg pMDI with charcoal ingestion
    Intervention: Procedure: charcoal block
  • Experimental: pMDI + Aerochamber Plus
    BDP/formoterol 100/6 µg with Aerochamber Plus
    Intervention: Device: Aerochamber Plus spacer
  • Active Comparator: pMDI
    BDP/formoterol 100/g µg pMDI
    Intervention: Drug: pMDI standard actuator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01280175
FB/PS/14/163/06
No
Sara Collarini / Clinical Study Manager, Chiesi Farmaceutici
Chiesi Farmaceutici S.p.A.
Cross Research S.A.
Principal Investigator: Antonio Rusca, MD, FMH CROSS Research SA
Chiesi Farmaceutici S.p.A.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP