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Completed

NCT Number: NCT01468272

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

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.

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Key information

Conditions

Asthma in Children

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BørneAstmaKlinikken, Hans Knudsens Plads 1A,

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

free comb. beclomethasone DPI and formoterol DPI

Drug

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 DPI

Drug

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. B17MP Cmax,Tmax,T1/2

    Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose

    BDP: profile of pharmacokinetics.

  2. BDP Area Under Curve (AUC), Cmax, Tmax, T1/2

    Time frame: predose, 15min,30min,1,2,4,6,8 hours postdose

    BDP: profile of Pharmacokinetics

  3. 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

  4. plasma potassium Area Under Curve (AUC), Cmin, Tmin

    Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose

    plasma potassium to evaluate drug systemic effect

  5. Heart Rate: Time averaged Heart Rate value: AUC0-t/t

    Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose

    Heart Rate to evaluate drug systemic effect

  6. 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

    Urinary cortisol to evaluate drug systemic effect

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: PAED4

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2011
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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