Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old (PAED1)

July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.

A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • BorneAstmaKlinikken

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 aged 5-11 years
  • 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 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-agonist treatment for a minimum of 4 h prior to each dose period.

    6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device 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 inclusion
  • Lower respiratory tract infection within 1 month prior to inclusion
  • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CHF1535 pMDI + AC Plus
Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
Drug: CHF1535 pMDI + AC Plus
Four inhalations for a total dose of BDP/FF 200/24 mcg
Other Names:
  • Fixed combination of BDP and FF 50/6 mcg
ACTIVE_COMPARATOR: BDP and Formoterol + AC Plus
Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
Drug: BDP + AC Plus
Four inhalations for a total dose of BDP 200 mcg
Other Names:
  • Beclomethasone Dipropionate 50 mcg with Aerochamber Plus
Drug: Formoterol + AC Plus
Four inhalations for a total dose of Formoterol 24 mcg
Other Names:
  • Formoterol 6 mcg with Aerochamebr Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B17MP AUC0-t
Time Frame: pre-dose until 8hours post dose
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
pre-dose until 8hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B17MP PK profile
Time Frame: pre-dose until 8 hours post-dose
pre-dose until 8 hours post-dose
BDP PK prolile
Time Frame: Pre-dose until 8 hours post-dose
Pre-dose until 8 hours post-dose
Formoterol PK profile
Time Frame: Pre-dose until 8 hours post-dose
Pre-dose until 8 hours post-dose
Plasma potassium AUC, Cmin, tmin
Time Frame: Pre-dose until 8 hours post-dose
Plasma potassium to evaluate drug systemic effect
Pre-dose until 8 hours post-dose
Urinary Cortisol excretion
Time Frame: Pre-dose until 8 hours post-dose
8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects
Pre-dose until 8 hours post-dose
Glucose in urine
Time Frame: Pre-dose until 8 hours post-dose
Glucose to evaluate the drug systemic effects
Pre-dose until 8 hours post-dose
Heart rate Time averaged heart rate value (AUC0-t)/t
Time Frame: Pre-dose until 8 hours post-dose
Heart rate to evaluate the drug systemic effects
Pre-dose until 8 hours post-dose
Spirometry: PEF
Time Frame: Pre-dose until 8 hours post-dose
Peak respiratory flow as a measure of drug efficacy
Pre-dose until 8 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Hans Bisgaard, MD DMSci, BorneAstmaKlinikken

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.

General Publications

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

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (ESTIMATE)

May 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-0902-PR-0013

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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