Healthy VolunteersPhase 1NCT01280175
Foster With or Without Charcoal Block or Aerochamber Plus
A Phase 1 study testing charcoal block, Aerochamber Plus spacer and pMDI standard actuator in people with Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- charcoal block, Aerochamber Plus spacer and pMDI standard actuator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2006to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Conditions
- Healthy Volunteers
- Being tested
- charcoal block, Aerochamber Plus spacer, pMDI standard actuator
- Keywords
- BDP, Formoterol, pMDI, Aerochamber Plus, Charcoal
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
charcoal blockProcedure or surgery
Aerochamber Plus spacerDevice
pMDI standard actuatorDrug
| Study group | Role | What they receive |
|---|---|---|
| pMDI + charcoal block | Experimental | BDP/formoterol 100/6 µg pMDI with charcoal ingestion Receives: Procedure: charcoal block |
| pMDI + Aerochamber Plus | Experimental | BDP/formoterol 100/6 µg with Aerochamber Plus Receives: Device: Aerochamber Plus spacer |
| pMDI | Active comparator | BDP/formoterol 100/g µg pMDI Receives: Drug: pMDI standard actuator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
Measured: from pre-dose until 12 h post-dose
Secondary outcomes (1)
General tolerability and safety of the test product.
Measured: from pre-dose until 12 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Investigators
- Antonio Rusca, MD, FMH, Principal investigator, CROSS Research SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280175
- Sponsor's protocol ID
- FB/PS/14/163/06
- Status last verified
- Jul 2020
- First submitted
- 17 Jan 2011
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh D, Collarini S, Poli G, Acerbi D, Amadasi A, Rusca A. Effect of AeroChamber Plus on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI. Br J Clin Pharmacol. 2011 Dec;72(6):932-9. doi: 10.1111/j.1365-2125.2011.04024.x.
PubMed 21615456
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01280175
- Acronym / sponsor ID
- FB/PS/14/163/06
- Conditions
- Healthy Volunteers
- Keywords
- BDP, Formoterol, pMDI, Aerochamber Plus, Charcoal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- Dec 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pMDI + charcoal block | Experimental | Procedure: charcoal blockBDP/formoterol 100/6 µg pMDI with charcoal ingestion |
| pMDI + Aerochamber Plus | Experimental | Device: Aerochamber Plus spacerBDP/formoterol 100/6 µg with Aerochamber Plus |
| pMDI | Active comparator | Drug: pMDI standard actuatorBDP/formoterol 100/g µg pMDI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| charcoal block | Procedure or surgery | pMDI + charcoal block |
| Aerochamber Plus spacer | Device | pMDI + Aerochamber Plus |
| pMDI standard actuator | Drug | pMDI |
Primary outcome
Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
Time frame: from pre-dose until 12 h post-dose
1 secondary outcome
General tolerability and safety of the test product.
Time frame: from pre-dose until 12 h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Results publication: PubMed 21615456Singh D, Collarini S, Poli G, Acerbi D, Amadasi A, Rusca A. Effect of AeroChamber Plus on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI. Br J Clin Pharmacol. 2011 Dec;72(6):932-9. doi: 10.1111/j.1365-2125.2011.04024.x.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Rusca, MD, FMH principal investigator
CROSS Research SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing charcoal block, Aerochamber Plus spacer and pMDI standard actuator in people with Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic exposure and lung bioavailability of BDP, B17MP and formoterol. (time frame: from pre-dose until 12 h post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.