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

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

      • Copenaghen, Denmark
        • BørneAstmaKlinikken, Hans Knudsens Plads 1A,

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
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
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
Urinary cortisol to evaluate drug systemic effect
from predose up to 8 hours postdose
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.

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

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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