- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02787967
Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
February 1, 2018 updated by: Chiesi Farmaceutici S.p.A.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenaghen, Denmark
- BørneAstmaKlinikken, Hans Knudsens Plads 1A,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NEXThaler® 35/4µg
CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations.
Total Dose: BDP 200µg FF 16µg
|
4 (four) inhalations (total dose: BDP/FF 140/16 µg)
|
Active Comparator: Reference treatment
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
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2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
predose, 15,30min, 1,2,4,6,8 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
B17MP Cmax
Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose
|
17MP: profile of pharmacokinetics
|
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
|
BDP: profile of Pharmacokinetics
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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: profile of pharmacokinetics
|
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: profile of pharmacokinetics
|
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: profile of pharmacokinetics
|
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
|
Formoterol: profile of pharmacokinetics
|
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 to evaluate drug systemic effect
|
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 to evaluate drug systemic effect
|
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
|
plasma potassium to evaluate drug systemic effect
|
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
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Urinary cortisol to evaluate drug systemic effect
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from predose up to 8 hours postdose
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B17MP Tmax
Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose
|
BDP: profile of pharmacokinetics
|
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: profile of pharmacokinetics
|
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: profile of pharmacokinetics
|
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: profile of pharmacokinetics
|
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
|
BDP: profile of pharmacokinetics
|
predose, 15min,30min,1,2,4,6,8 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans Bisgaard, MD, Copenhagen Studies on Asthma in Childhood
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
March 15, 2016
First Submitted That Met QC Criteria
May 26, 2016
First Posted (Estimate)
June 2, 2016
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
February 1, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Beclomethasone
- Formoterol Fumarate
Other Study ID Numbers
- CCD-01535BB1-01
- 2015-005152-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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