Asthma in ChildrenPhase 2PAED4NCT01468272
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
A Phase 2 study testing free comb. beclomethasone DPI and formoterol DPI and CHF 1535 50/6 NEXT DPI in people with Asthma in Children, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
Trial summary
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- free comb. beclomethasone DPI and formoterol DPI and CHF 1535 50/6 NEXT DPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Aug 2012
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male/Female children aged 5 -11y
- Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
- Children with stable asthma
- Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
- Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
- A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.
Who cannot join
- Past or present diagnoses of cardiovascular, renal or liver disease
- Known hypersensitivity to the active treatments
- Exacerbation of asthma symptoms within the previous 4 weeks
- Inability to perform the required breathing technique and blood sampling
- Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
- Lower respiratory tract infection within 1 month prior to screening (visit 1)
- Disease (other than asthma) which might influence the outcome of the study
- Obesity, i.e. > 97% weight percentile by local standards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose,Open-label,Randomized,2-way Cross-over,Clinical Pharmacology Study of CHF1535 50/6 NEXT DPI® Fixed Combination of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6µg)Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Children
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Read the detailed description
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
- Conditions
- Asthma in Children
- Being tested
- free comb. beclomethasone DPI and formoterol DPI, CHF 1535 50/6 NEXT DPI
- Keywords
- asthma children NEXT DPI LABA ICS inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free comb. beclomethasone DPI and formoterol DPIDrug
free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).
CHF 1535 50/6 NEXT DPIDrug
four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)
| Study group | Role | What they receive |
|---|---|---|
| reference treatment | Active comparator | Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI Receives: Drug: free comb. beclomethasone DPI and formoterol DPI |
| CHF 1535 NEXT DPI | Experimental | CHF 1535 50/6 NEXT DPI Receives: Drug: CHF 1535 50/6 NEXT DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
B17MP (active metabolite of BDP) Area Under Curve (AUC)
B17MP: Profile of Pharmacokinetics
Measured: predose, 15,30min, 1,2,4,6,8 hours post dose
Secondary outcomes (6)
B17MP Cmax,Tmax,T1/2
BDP: profile of pharmacokinetics.
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Area Under Curve (AUC), Cmax, Tmax, T1/2
BDP: profile of Pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours postdose
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2
Formoterol: profile of pharmacokinetics
Measured: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
plasma potassium Area Under Curve (AUC), Cmin, Tmin
plasma potassium to evaluate drug systemic effect
Measured: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Heart Rate: Time averaged Heart Rate value: AUC0-t/t
Heart Rate to evaluate drug systemic effect
Measured: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).
Urinary cortisol to evaluate drug systemic effect
Measured: from predose up to 8 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
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 Asthma in ChildrenStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Bisgaard, Principal investigator, BorneAstmaKlinikken, Copenaghen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468272
- Sponsor's protocol ID
- CCD-1103-PR-0058
- Acronym
- PAED4
- Status last verified
- Jul 2020
- First submitted
- 28 Oct 2011
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17.
PubMed 24993817
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 Single-dose,Open-label,Randomized,2-way Cross-over,Clinical Pharmacology Study of CHF1535 50/6 NEXT DPI® Fixed Combination of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6µg)Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Children
- ClinicalTrials.gov ID
- NCT01468272
- Acronym / sponsor ID
- PAED4 / CCD-1103-PR-0058
- Conditions
- Asthma in Children
- Keywords
- asthma children NEXT DPI LABA ICS inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Nov 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.
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Detailed description
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference treatment | Active comparator | Drug: free comb. beclomethasone DPI and formoterol DPIFree combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI |
| CHF 1535 NEXT DPI | Experimental | Drug: CHF 1535 50/6 NEXT DPICHF 1535 50/6 NEXT DPI |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male/Female children aged 5 -11y
- Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
- Children with stable asthma
- Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
- Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
Key exclusion criteria (8 listed)
- Past or present diagnoses of cardiovascular, renal or liver disease
- Known hypersensitivity to the active treatments
- Exacerbation of asthma symptoms within the previous 4 weeks
- Inability to perform the required breathing technique and blood sampling
- Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
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 |
|---|---|---|
| free comb. beclomethasone DPI and formoterol DPIfree combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug). | Drug | reference treatment |
| CHF 1535 50/6 NEXT DPIfour inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug) | Drug | CHF 1535 NEXT DPI |
Primary outcome
B17MP (active metabolite of BDP) Area Under Curve (AUC)
Time frame: predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP: Profile of Pharmacokinetics
6 secondary outcomes
B17MP Cmax,Tmax,T1/2
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Area Under Curve (AUC), Cmax, Tmax, T1/2
Time frame: predose, 15min,30min,1,2,4,6,8 hours postdose
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
plasma potassium Area Under Curve (AUC), Cmin, Tmin
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Heart Rate: Time averaged Heart Rate value: AUC0-t/t
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).
Time frame: from predose up to 8 hours postdose
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.
- Results publication: PubMed 24993817Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17.
- 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.
Hans Bisgaard principal investigator
BorneAstmaKlinikken, Copenaghen, Denmark
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 free comb. beclomethasone DPI and formoterol DPI and CHF 1535 50/6 NEXT DPI in people with Asthma in Children, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
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 6 inclusion and 8 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 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 1 site in Denmark. 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?
B17MP (active metabolite of BDP) Area Under Curve (AUC) (time frame: predose, 15,30min, 1,2,4,6,8 hours 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 NCT01468272, 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 31 Jul 2020.