AsthmaPhase 2ADONENCT01191424
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
A Phase 2 study testing CHF1535 NEXT DPI and BDP DPI and formoterol DPI in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF1535 NEXT DPI and BDP DPI and formoterol DPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2010to Sep 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
- Written informed consent;
- Diagnosis of asthma as defined in the GINA guidelines;
- Patients with stable asthma, according to the Investigator's opinion;
- Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
- Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
- Patients with a peak inspiratory flow (PIF) > 40 L/min
- Reversibility test;
- Non- or ex-smokers;
- A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;
Main Exclusion Criteria:
- Pregnant or lactating female;
- Having received an investigational drug within 2 months before the screening visit
- Diagnosis of COPD as defined by the current GOLD guidelines;
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
- Known hypersensitivity to the active treatments;
- History of drug addiction or excessive use of alcohol;
- Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
- Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
- Inability to perform the required breathing technique and blood sampling;
- Lower respiratory tract infection within 1 month prior to the screening visit;
- Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.
- Conditions
- Asthma
- Being tested
- CHF1535 NEXT DPI, BDP DPI and formoterol DPI
- Keywords
- Asthma, PK, Adolescents, Adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF1535 NEXT DPIDrug
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
BDP DPI and formoterol DPIDrug
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
| Study group | Role | What they receive |
|---|---|---|
| CHF1535 NEXT DPI | Experimental | Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI Receives: Drug: CHF1535 NEXT DPI |
| Free combination BDP and FF | Active comparator | Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF Receives: Drug: BDP DPI and formoterol DPI |
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) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
Plasma AUC0-t for B17MP
Measured: 0-8hrs
Secondary outcomes (6)
Different pharmacokinetic parameters
BDP/B17MP and FF PK parameters
Measured: 0-8hrs
Lung function parameters
Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).
Measured: 0-8hrs
Plasma potassium
Plasma Potassium Cmin, tmin and AUC0-t
Measured: 0-8hrs
Plasma glucose
Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t
Measured: 0-8hrs
Heart rate
time averaged value (AUC0-t/8)
Measured: 0-8hrs
Adverse Events
Measured: during the whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 57 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, Study director, Medicines Evaluation UnitHans Bisgaard, MD, Study director, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191424
- Sponsor's protocol ID
- CCD-1017-PR-0034
- Other IDs
- 2010-018947-33
- Acronym
- ADONE
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2010
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.
PubMed 24746942Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available.
PubMed 24830339
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
- ClinicalTrials.gov ID
- NCT01191424
- Acronym / sponsor ID
- ADONE / CCD-1017-PR-0034
- Conditions
- Asthma
- Keywords
- Asthma, PK, Adolescents, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Aug 2010 (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 demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF1535 NEXT DPI | Experimental | Drug: CHF1535 NEXT DPIMale and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI |
| Free combination BDP and FF | Active comparator | Drug: BDP DPI and formoterol DPIMale and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CHF1535 NEXT DPIFIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER | Drug | CHF1535 NEXT DPI |
| BDP DPI and formoterol DPIFREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI | Drug | Free combination BDP and FF |
Primary outcome
Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
Time frame: 0-8hrs
Plasma AUC0-t for B17MP
6 secondary outcomes
Different pharmacokinetic parameters
Time frame: 0-8hrs
Lung function parameters
Time frame: 0-8hrs
Plasma potassium
Time frame: 0-8hrs
Plasma glucose
Time frame: 0-8hrs
Heart rate
Time frame: 0-8hrs
Adverse Events
Time frame: during the whole study period
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 31 Jul 2020.
- Background: PubMed 24746942Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.
- Results publication: PubMed 24830339Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available.
- 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 study director
Medicines Evaluation Unit
Hans Bisgaard, MD study director
Copenhagen University Hospital at Herlev
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF1535 NEXT DPI and BDP DPI and formoterol DPI in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, 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) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI (time frame: 0-8hrs). 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 NCT01191424, which also lists 2 linked publications.
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 31 Jul 2020.