AsthmaPhase 2NCT01370031
Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices
A Phase 2 study testing Clenil® Modulite® via AeroChamber Plus™, Clenil® Modulite® via Volumatic™ spacer and Clenil® Modulite® via AeroChamber Plus™ plus charcoal block in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Clenil® Modulite® via AeroChamber Plus™, Clenil® Modulite® via Volumatic™ spacer and Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jun 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female patients aged 18-65 years included.
- Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
- Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
- FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation
Who cannot join
- Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
- Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
- Lower respiratory tract infection within one month prior to screening.
- Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
- Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
- Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening.
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- Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit)
- Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study.
- Blood donation (450 mL or more)or significant blood loss less than 12 weeks before the first intake of study drug.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester
About this study
Official title: Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients
The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.
- Conditions
- Asthma
- Being tested
- Clenil® Modulite® via AeroChamber Plus™, Clenil® Modulite® via Volumatic™ spacer, Clenil® Modulite® via AeroChamber Plus™ plus charcoal block, Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
- Keywords
- Asthma, PK, Adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clenil® Modulite® via AeroChamber Plus™Drug
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
Clenil® Modulite® via Volumatic™ spacerDrug
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
Clenil® Modulite® via AeroChamber Plus™ plus charcoal blockDrug
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
Clenil® Modulite® administered via Volumatic™ spacer plus charcoal blockDrug
Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)
| Study group | Role | What they receive |
|---|---|---|
| Clenil® Modulite® via AeroChamber Plus™ | Experimental | Clenil® Modulite® administered via AeroChamber Plus™ spacer Receives: Drug: Clenil® Modulite® via AeroChamber Plus™ |
| Clenil® Modulite® via Volumatic™ | Active comparator | Clenil® Modulite® administered via Volumatic™ spacer Receives: Drug: Clenil® Modulite® via Volumatic™ spacer |
| Clenil® Modulite® via AeroChamber Plus™ plus charcoal block | Experimental | Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block Receives: Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block |
| Clenil® Modulite® via Volumatic™ plus charcoal block | Active comparator | Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block Receives: Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Plasma AUC0-12h,ss for B17MP
Measured: 0-12 hours
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Plasma Cmax,ss for B17MP
Measured: 0-12 hours
Secondary outcomes (5)
evaluation of the pharmacokinetic profile of BDP
AUC and Cmax for BDP
Measured: 0-12 hours
Vital signs assessment
Heart rate and Blood pressure assessment
Measured: from screening (week -1) to week 8
haematology and blood chemistry assessment
haematology and blood chemistry assessment
Measured: at screening (week - 1) and week 8
Number of patients with Adverse events
Adverse events
Measured: during the 11 weeks of study
FEV1 predose assessment
FEV1 predose assessment as lung function parameter
Measured: from screening (week-1) to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicine Evaluation Unit, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370031
- Sponsor's protocol ID
- CCD-1008-PR-0049
- Other IDs
- 2010-022615-19
- Status last verified
- Mar 2017
- First submitted
- 28 Apr 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients
- ClinicalTrials.gov ID
- NCT01370031
- Acronym / sponsor ID
- CCD-1008-PR-0049
- Conditions
- Asthma
- Keywords
- Asthma, PK, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Jun 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, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clenil® Modulite® via AeroChamber Plus™ | Experimental | Drug: Clenil® Modulite® via AeroChamber Plus™Clenil® Modulite® administered via AeroChamber Plus™ spacer |
| Clenil® Modulite® via Volumatic™ | Active comparator | Drug: Clenil® Modulite® via Volumatic™ spacerClenil® Modulite® administered via Volumatic™ spacer |
| Clenil® Modulite® via AeroChamber Plus™ plus charcoal block | Experimental | Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal blockClenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block |
| Clenil® Modulite® via Volumatic™ plus charcoal block | Active comparator | Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal blockClenil® Modulite® administered via Volumatic™ spacer plus charcoal block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female patients aged 18-65 years included.
- Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
- Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
- FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation
Key exclusion criteria (9 listed)
- Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
- Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
- Lower respiratory tract infection within one month prior to screening.
- Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
- Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
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 |
|---|---|---|
| Clenil® Modulite® via AeroChamber Plus™Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days | Drug | Clenil® Modulite® via AeroChamber Plus™ |
| Clenil® Modulite® via Volumatic™ spacerClenil® Modulite® 250 µg via Volumatic™ spacer during 14 days | Drug | Clenil® Modulite® via Volumatic™ |
| Clenil® Modulite® via AeroChamber Plus™ plus charcoal blockClenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14) | Drug | Clenil® Modulite® via AeroChamber Plus™ plus charcoal block |
| Clenil® Modulite® administered via Volumatic™ spacer plus charcoal blockClenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14) | Drug | Clenil® Modulite® via Volumatic™ plus charcoal block |
Primary outcome
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Time frame: 0-12 hours
Plasma AUC0-12h,ss for B17MP
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Time frame: 0-12 hours
Plasma Cmax,ss for B17MP
5 secondary outcomes
evaluation of the pharmacokinetic profile of BDP
Time frame: 0-12 hours
Vital signs assessment
Time frame: from screening (week -1) to week 8
haematology and blood chemistry assessment
Time frame: at screening (week - 1) and week 8
Number of patients with Adverse events
Time frame: during the 11 weeks of study
FEV1 predose assessment
Time frame: from screening (week-1) to week 8
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 30 Mar 2017.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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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.
Dave Singh, MD principal investigator
Medicine Evaluation Unit, Manchester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clenil® Modulite® via AeroChamber Plus™, Clenil® Modulite® via Volumatic™ spacer and Clenil® Modulite® via AeroChamber Plus™ plus charcoal block in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
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 4 inclusion and 9 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 30 Mar 2017. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® (time frame: 0-12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2017.