AsthmaPhase 2PAED1NCT01848769
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
A Phase 2 study testing CHF1535 pMDI + AC Plus, BDP + AC Plus and Formoterol + AC Plus in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
Trial summary
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old). Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF1535 pMDI + AC Plus, BDP + AC Plus and Formoterol + AC Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Dec 2010
- 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 5-11 years
- 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 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-agonist treatment for a minimum of 4 h prior to each dose period.
- 6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device 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 inclusion
- Lower respiratory tract infection within 1 month prior to inclusion
- 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, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
- Conditions
- Asthma
- Being tested
- CHF1535 pMDI + AC Plus, BDP + AC Plus, Formoterol + AC Plus
- Keywords
- Asthma, ICS+LABA, Children, Inhalation, pMDI
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF1535 pMDI + AC PlusDrug
Also called Fixed combination of BDP and FF 50/6 mcg
Four inhalations for a total dose of BDP/FF 200/24 mcg
BDP + AC PlusDrug
Also called Beclomethasone Dipropionate 50 mcg with Aerochamber Plus
Four inhalations for a total dose of BDP 200 mcg
Formoterol + AC PlusDrug
Also called Formoterol 6 mcg with Aerochamebr Plus
Four inhalations for a total dose of Formoterol 24 mcg
| Study group | Role | What they receive |
|---|---|---|
| CHF1535 pMDI + AC Plus | Experimental | Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device Receives: Drug: CHF1535 pMDI + AC Plus |
| BDP and Formoterol + AC Plus | Active comparator | Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device Receives: Drug: BDP + AC Plus; Drug: Formoterol + AC Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
B17MP AUC0-t
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
Measured: pre-dose until 8hours post dose
Secondary outcomes (8)
B17MP PK profile
Measured: pre-dose until 8 hours post-dose
BDP PK prolile
Measured: Pre-dose until 8 hours post-dose
Formoterol PK profile
Measured: Pre-dose until 8 hours post-dose
Plasma potassium AUC, Cmin, tmin
Plasma potassium to evaluate drug systemic effect
Measured: Pre-dose until 8 hours post-dose
Urinary Cortisol excretion
8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects
Measured: Pre-dose until 8 hours post-dose
Glucose in urine
Glucose to evaluate the drug systemic effects
Measured: Pre-dose until 8 hours post-dose
Heart rate Time averaged heart rate value (AUC0-t)/t
Heart rate to evaluate the drug systemic effects
Measured: Pre-dose until 8 hours post-dose
Spirometry: PEF
Peak respiratory flow as a measure of drug efficacy
Measured: Pre-dose until 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Bisgaard, MD DMSci, Principal investigator, BorneAstmaKlinikken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848769
- Sponsor's protocol ID
- CCD-0902-PR-0013
- Acronym
- PAED1
- Status last verified
- Jul 2020
- First submitted
- 3 May 2013
- 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, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.
PubMed 22978252
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, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children
- ClinicalTrials.gov ID
- NCT01848769
- Acronym / sponsor ID
- PAED1 / CCD-0902-PR-0013
- Conditions
- Asthma
- Keywords
- Asthma, ICS+LABA, Children, Inhalation, pMDI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 May 2013 (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 rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF1535 pMDI + AC Plus | Experimental | Drug: CHF1535 pMDI + AC PlusFixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device |
| BDP and Formoterol + AC Plus | Active comparator | Drug: BDP + AC Plus, Drug: Formoterol + AC PlusBeclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male/Female children aged 5-11 years
- 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 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-agonist treatment for a minimum of 4 h prior to each dose period.
- 6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.
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 inclusion
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 pMDI + AC PlusAlso: Fixed combination of BDP and FF 50/6 mcgFour inhalations for a total dose of BDP/FF 200/24 mcg | Drug | CHF1535 pMDI + AC Plus |
| BDP + AC PlusAlso: Beclomethasone Dipropionate 50 mcg with Aerochamber PlusFour inhalations for a total dose of BDP 200 mcg | Drug | BDP and Formoterol + AC Plus |
| Formoterol + AC PlusAlso: Formoterol 6 mcg with Aerochamebr PlusFour inhalations for a total dose of Formoterol 24 mcg | Drug | BDP and Formoterol + AC Plus |
Primary outcome
B17MP AUC0-t
Time frame: pre-dose until 8hours post dose
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
8 secondary outcomes
B17MP PK profile
Time frame: pre-dose until 8 hours post-dose
BDP PK prolile
Time frame: Pre-dose until 8 hours post-dose
Formoterol PK profile
Time frame: Pre-dose until 8 hours post-dose
Plasma potassium AUC, Cmin, tmin
Time frame: Pre-dose until 8 hours post-dose
Urinary Cortisol excretion
Time frame: Pre-dose until 8 hours post-dose
Glucose in urine
Time frame: Pre-dose until 8 hours post-dose
Heart rate Time averaged heart rate value (AUC0-t)/t
Time frame: Pre-dose until 8 hours post-dose
Spirometry: PEF
Time frame: Pre-dose until 8 hours 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 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 22978252Chawes BL, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.
- 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, MD DMSci principal investigator
BorneAstmaKlinikken
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 CHF1535 pMDI + AC Plus, BDP + AC Plus and Formoterol + AC Plus in people with Asthma, 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 5 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 AUC0-t (time frame: pre-dose until 8hours 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 NCT01848769, 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.