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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NEXThaler® 35/4µg
CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg
Drug: CHF 1535 35/4µg NEXThaler®
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiesi Farmaceutici S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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