- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280175
Foster With or Without Charcoal Block or Aerochamber Plus
July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Via F.A. Giorgioli, 14
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Arzo, Via F.A. Giorgioli, 14, Switzerland, 6864
- CROSS Research SA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: pMDI + charcoal block
BDP/formoterol 100/6 µg pMDI with charcoal ingestion
|
|
EXPERIMENTAL: pMDI + Aerochamber Plus
BDP/formoterol 100/6 µg with Aerochamber Plus
|
|
ACTIVE_COMPARATOR: pMDI
BDP/formoterol 100/g µg pMDI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
Time Frame: from pre-dose until 12 h post-dose
|
from pre-dose until 12 h post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General tolerability and safety of the test product.
Time Frame: from pre-dose until 12 h post-dose
|
from pre-dose until 12 h post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonio Rusca, MD, FMH, CROSS Research SA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (ACTUAL)
February 1, 2007
Study Completion (ACTUAL)
February 1, 2007
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 19, 2011
First Posted (ESTIMATE)
January 20, 2011
Study Record Updates
Last Update Posted (ACTUAL)
August 3, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FB/PS/14/163/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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