AsthmaPhase 2NCT02787967
Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
A Phase 2 study testing CHF 1535 35/4µg NEXThaler® and free comb. beclomethasone DPI and formoterol DPI in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
Trial summary
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF 1535 35/4µg NEXThaler® and free comb. beclomethasone DPI and formoterol DPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Jun 2017
- 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 with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
- Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
- Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
- Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
- A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures
Who cannot join
- Past or present diagnosis of cardiovascular, renal or liver disease.
- Known hypersensitivity to the active treatmen
- Exacerbation of asthma symptoms within 4 weeks prior to screening.
- 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 Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI
Read the detailed description
This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
- Conditions
- Asthma
- Being tested
- CHF 1535 35/4µg NEXThaler®, free comb. beclomethasone DPI and formoterol DPI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 1535 35/4µg NEXThaler®Drug
4 (four) inhalations (total dose: BDP/FF 140/16 µg)
free comb. beclomethasone DPI and formoterol DPIDrug
2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
| Study group | Role | What they receive |
|---|---|---|
| NEXThaler® 35/4µg | Experimental | CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg Receives: Drug: CHF 1535 35/4µg NEXThaler® |
| Reference treatment | Active comparator | Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg Receives: Drug: free comb. beclomethasone DPI and formoterol DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP
B17MP: Profile of Pharmacokinetics
Measured: predose, 15,30min, 1,2,4,6,8 hours post dose
Secondary outcomes (15)
B17MP Cmax
17MP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Area Under Curve (AUC)
BDP: profile of Pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
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
Formoterol Cmax
Formoterol: profile of pharmacokinetics
Measured: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Formoterol Tmax
Formoterol: profile of pharmacokinetics
Measured: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Formoterol T1/2
Formoterol: profile of pharmacokinetics
Measured: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
plasma potassium Area Under Curve (AUC)
plasma potassium to evaluate drug systemic effect
Measured: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
plasma potassium Cmin
plasma potassium to evaluate drug systemic effect
Measured: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
plasma potassium Tmin
plasma potassium 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
B17MP Tmax
BDP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
B17MP T1/2
BDP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Cmax
BDP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Tmax
BDP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP T1/2
BDP: profile of pharmacokinetics
Measured: predose, 15min,30min,1,2,4,6,8 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 posted2 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
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
- 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, MD, Principal investigator, Copenhagen Studies on Asthma in Childhood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787967
- Sponsor's protocol ID
- CCD-01535BB1-01
- Other IDs
- 2015-005152-10, 2015
- Status last verified
- Feb 2018
- First submitted
- 15 Mar 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. 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 Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children
- ClinicalTrials.gov ID
- NCT02787967
- Acronym / sponsor ID
- CCD-01535BB1-01
- Conditions
- Asthma
- 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
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Jun 2016 (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 study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI
Detailed description
This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEXThaler® 35/4µg | Experimental | Drug: CHF 1535 35/4µg NEXThaler®CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg |
| Reference treatment | Active comparator | Drug: free comb. beclomethasone DPI and formoterol DPIDrug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg |
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 with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
- Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
- Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
- Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
- A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures
Key exclusion criteria (8 listed)
- Past or present diagnosis of cardiovascular, renal or liver disease.
- Known hypersensitivity to the active treatmen
- Exacerbation of asthma symptoms within 4 weeks prior to screening.
- 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 |
|---|---|---|
| CHF 1535 35/4µg NEXThaler®4 (four) inhalations (total dose: BDP/FF 140/16 µg) | Drug | NEXThaler® 35/4µg |
| free comb. beclomethasone DPI and formoterol DPI2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg | Drug | Reference treatment |
Primary outcome
Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP
Time frame: predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP: Profile of Pharmacokinetics
15 secondary outcomes
B17MP Cmax
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Area Under Curve (AUC)
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Formoterol Cmax
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Formoterol Tmax
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Formoterol T1/2
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
plasma potassium Area Under Curve (AUC)
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
plasma potassium Cmin
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
plasma potassium Tmin
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
B17MP Tmax
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
B17MP T1/2
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Cmax
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Tmax
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP T1/2
Time frame: predose, 15min,30min,1,2,4,6,8 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 5 Feb 2018.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 principal investigator
Copenhagen Studies on Asthma in Childhood
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 CHF 1535 35/4µg NEXThaler® and free comb. beclomethasone DPI and formoterol DPI 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 5 Feb 2018. 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?
Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP (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?
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 5 Feb 2018.