Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children (PAED3)

March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.

Double Blind, Double Dummy, Cross-over Study to Compare the Bronchodilator Effect of CHF1535 pMDI (Fixed Combination of Beclometasone 50 µg + Formoterol 6 µg) Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children

The purpose of this clinical study is to compare the improvement in breathing of single administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose 100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg) given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.

Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to placebo and the effect on other lung function parameters, to assess the safety and tolerability of CHF 1535 dosages in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FEV1 from 0 to 12 hours standardised by time will be statistically analysed taking into account treatment, period and subject and pre-dose FEV1.

Study Type

Interventional

Enrollment (Actual)

59

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

  • Poland
    • Debica, Poland
      • Debica, Debica, Poland, Poland, 39 -200
        • Poradnia Alergologiczna
  • Ukraine
      • Zaporizhzhia, Ukraine, 69063
        • Zaporizhzhia State Medical University

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:

  • Written informed consent obtained from the parents/legal representatives and/or the subject (if and when appropriate)
  • Prepuberal male and female outpatients, aged ≥ 5 and < 12 years (Tanner stage I and II)
  • Clinical diagnosis of asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2009 at least six months prior to screening visit.
  • Already treated with inhaled short acting Beta2-agonists as required and / or inhaled beclomethasone dipropionate up to 400 µg or equivalent.
  • Forced Expiratory Volume during the first second (FEV1) ≥ 60% and ≤ 95% of predicted normal values at the screening visit.
  • A documented positive response to the reversibility test at the screening visit, defined as Delta FEV1 ≥ 15% over baseline, 15 minutes after 400 μg salbutamol pressurised Meter Dose Inhaler (ATS/ERS taskforce 2005).
  • A cooperative attitude and ability to use a pMDI and a spacer (Aerochamber Plus and Volumatic).

Exclusion Criteria:

  • Endocrinological diseases or other chronic diseases.
  • Known sensitivity to the components of study medication.
  • Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids.
  • Allergy to one component of medications used.
  • Intolerance or contra-indication to treatment with Beta2-agonists and/or inhaled corticosteroids.
  • Having received an investigational drug within 2 months before the current study.
  • Inability to comply to study procedures or to study treatment intake.
  • Occurrence of acute asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
  • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
  • History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit).
  • Diagnosis of restrictive lung disease.
  • Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.
  • QTc interval (Fridericia's formula) higher than 450 msec at screening visit

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
CHF 1535 50/6 administered via a pMDI with spacer, 1 inhalation (dose: BDP 50 µg/FF 6 µg) + placebo HFA pMDI with spacer, 5 inhalations in the morning at the clinic
Drug: beclomethasone+formoterol 50/6 (1 inhalation)
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Other Names:
  • CHF1535, Atimos®, Ventolair®, Ventolin®
Experimental: Treatment B:
CHF 1535 50/6 administered via a pMDI with spacer, 2 inhalations (dose: BDP 100 µg/FF 12 µg) + placebo HFA pMDI with spacer, 4 inhalations in the morning at the clinic
Drug: CHF 1535 50/6 (2 inhalations)
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Other Names:
  • CHF1535, Atimos®, Ventolair®, Ventolin®
Experimental: Treatment C
CHF 1535 50/6 (dose: BDP 200 µg/FF 24 µg) administered via a pMDI with spacer, 4 inhalations (dose: BDP 200 µg/FF 24 µg) in the morning at the clinic + placebo HFA pMDI with spacer, 2 inhalations in the morning at the clinic
Drug: CHF 1535 50/6 (4 inhalations)
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Other Names:
  • CHF1535, Atimos®, Ventolair®, Ventolin®
Active Comparator: Treatment D
formoterol 6 µg HFA administered via a pMDI with spacer, 2 inhalations (dose: FF 12 µg) + extrafine BDP 50 µg, administered via a pMDI with spacer, 2 inhalations (dose: BDP 100 µg), in the morning at the clinic + placebo HFA pMDI with spacer, 2 inhalations in the morning at the clinic
Drug: Formoterol + Beclomethasone dipropionate
  • Formoterol HFA pMDI 6 µg / actuation
  • Extrafine BDP HFA pMDI 50 µg/actuation
Other Names:
  • CHF1535, Atimos®, Ventolair®, Ventolin®
Placebo Comparator: Treatment E
placebo pMDI with spacer, 6 inhalations in the morning at the clinic
Drug: Placebo (6 inhalations)
Matched placebo via pMDI
Other Names:
  • CHF1535, Atimos®, Ventolair®, Ventolin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bronchodilator effect of test treatment
Time Frame: FEV1 AUC measured over 12 hours
To compare the bronchodilator effect of single administration of CHF 1535 50/6 pMDI (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose, 2 inhalations, total dose 100/12 µg) given with spacer vs. free combination of extrafine beclomethasone dipropionate 50 µg/metered dose pMDI (2 inhalations, total dose 100 µg) given with spacer plus formoterol 6 µg/metered dose pMDI (2 inhalations, total dose 12 µg) given with spacer in terms of FEV1 AUC 0-12 hours corrected by time for the 12 hours study period in asthmatic children.
FEV1 AUC measured over 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose-related effects of test treatment
Time Frame: Peak FEV1 and FEV1 measured at 12 hours post-dose
To evaluate the dose-related effects of CHF 1535 pMDI compared to placebo and the effect on other lung function parameters, to assess the safety and tolerability of CHF 1535 regimens in children.
Peak FEV1 and FEV1 measured at 12 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: Petr Pohunek, M.D., Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC

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

December 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-0903-PR-0060
  • 2011-002060-24 (EudraCT Number)

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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