Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old (PAED4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01468272
First received: October 28, 2011
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Asthma in Children
Drug: free comb. beclomethasone DPI and formoterol DPI
Drug: CHF 1535 50/6 NEXT DPI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • B17MP (active metabolite of BDP) Area Under Curve (AUC) [ Time Frame: predose, 15,30min, 1,2,4,6,8 hours post dose ] [ Designated as safety issue: No ]
    B17MP: Profile of Pharmacokinetics


Secondary Outcome Measures:
  • B17MP Cmax,Tmax,T1/2 [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ] [ Designated as safety issue: No ]
    BDP: profile of pharmacokinetics.

  • BDP Area Under Curve (AUC), Cmax, Tmax, T1/2 [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours postdose ] [ Designated as safety issue: No ]
    BDP: profile of Pharmacokinetics

  • Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [ Time Frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose ] [ Designated as safety issue: No ]
    Formoterol: profile of pharmacokinetics

  • plasma potassium Area Under Curve (AUC), Cmin, Tmin [ Time Frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose ] [ Designated as safety issue: No ]
    plasma potassium to evaluate drug systemic effect

  • Heart Rate: Time averaged Heart Rate value: AUC0-t/t [ Time Frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose ] [ Designated as safety issue: No ]
    Heart Rate to evaluate drug systemic effect

  • 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 ] [ Designated as safety issue: No ]
    Urinary cortisol to evaluate drug systemic effect


Enrollment: 26
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: reference treatment
Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI
Drug: free comb. beclomethasone DPI and formoterol DPI
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).
Experimental: CHF 1535 NEXT DPI
CHF 1535 50/6 NEXT DPI
Drug: CHF 1535 50/6 NEXT DPI
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)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/Female children aged 5 -11y
  2. Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
  3. Children with stable asthma
  4. Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
  5. 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.
  6. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.

Exclusion Criteria:

  1. Past or present diagnoses of cardiovascular, renal or liver disease
  2. Known hypersensitivity to the active treatments
  3. Exacerbation of asthma symptoms within the previous 4 weeks
  4. Inability to perform the required breathing technique and blood sampling
  5. Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
  6. Lower respiratory tract infection within 1 month prior to screening (visit 1)
  7. Disease (other than asthma) which might influence the outcome of the study
  8. Obesity, i.e. > 97% weight percentile by local standards
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468272

Locations
Denmark
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenhagen,, Denmark, 2100
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Hans Bisgaard BorneAstmaKlinikken, Copenaghen, Denmark
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01468272     History of Changes
Other Study ID Numbers: CCD-1103-PR-0058
Study First Received: October 28, 2011
Last Updated: April 29, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Chiesi Farmaceutici S.p.A.:
asthma children NEXT DPI LABA ICS inhalation

Additional relevant MeSH terms:
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014