search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
beclomethasone+formoterol 50/6 (1 inhalation)
CHF 1535 50/6 (2 inhalations)
CHF 1535 50/6 (4 inhalations)
Formoterol + Beclomethasone dipropionate
Placebo (6 inhalations)
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Poradnia Alergologiczna
  • Zaporizhzhia State Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Treatment A

Treatment B:

Treatment C

Treatment D

Treatment E

Arm Description

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

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

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

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

placebo pMDI with spacer, 6 inhalations in the morning at the clinic

Outcomes

Primary Outcome Measures

bronchodilator effect of test treatment
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.

Secondary Outcome Measures

dose-related effects of test treatment
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.

Full Information

First Posted
April 23, 2012
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT01584492
Brief Title
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children
Acronym
PAED3
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment B:
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment D
Arm Type
Active Comparator
Arm Description
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
Arm Title
Treatment E
Arm Type
Placebo Comparator
Arm Description
placebo pMDI with spacer, 6 inhalations in the morning at the clinic
Intervention Type
Drug
Intervention Name(s)
beclomethasone+formoterol 50/6 (1 inhalation)
Other Intervention Name(s)
CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention Description
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Intervention Type
Drug
Intervention Name(s)
CHF 1535 50/6 (2 inhalations)
Other Intervention Name(s)
CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention Description
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Intervention Type
Drug
Intervention Name(s)
CHF 1535 50/6 (4 inhalations)
Other Intervention Name(s)
CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention Description
CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
Intervention Type
Drug
Intervention Name(s)
Formoterol + Beclomethasone dipropionate
Other Intervention Name(s)
CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention Description
Formoterol HFA pMDI 6 µg / actuation Extrafine BDP HFA pMDI 50 µg/actuation
Intervention Type
Drug
Intervention Name(s)
Placebo (6 inhalations)
Other Intervention Name(s)
CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention Description
Matched placebo via pMDI
Primary Outcome Measure Information:
Title
bronchodilator effect of test treatment
Description
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.
Time Frame
FEV1 AUC measured over 12 hours
Secondary Outcome Measure Information:
Title
dose-related effects of test treatment
Description
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.
Time Frame
Peak FEV1 and FEV1 measured at 12 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Pohunek, M.D.
Organizational Affiliation
Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poradnia Alergologiczna
City
Debica
State/Province
Debica, Poland
ZIP/Postal Code
39 -200
Country
Poland
Facility Name
Zaporizhzhia State Medical University
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
33404895
Citation
Pohunek P, Varoli G, Reznichenko Y, Mokia-Serbina S, Brzostek J, Kostromina V, Kaladze M, Muraro A, Carzana E, Armani S, Kaczmarek J. Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study. Eur J Pediatr. 2021 May;180(5):1467-1475. doi: 10.1007/s00431-020-03888-x. Epub 2021 Jan 6.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-002060-24
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

We'll reach out to this number within 24 hrs