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

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ClinicalTrials.gov Identifier: NCT01584492
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: beclomethasone+formoterol 50/6 (1 inhalation) Drug: CHF 1535 50/6 (2 inhalations) Drug: CHF 1535 50/6 (4 inhalations) Drug: Formoterol + Beclomethasone dipropionate Drug: Placebo (6 inhalations) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CHF1535, Atimos®, Ventolair®, Ventolin®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584492


Locations
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Poland
Poradnia Alergologiczna
Debica, Debica, Poland, Poland, 39 -200
Ukraine
Zaporizhzhia State Medical University
Zaporizhzhia, Ukraine, 69063
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Petr Pohunek, M.D. Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC

Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01584492     History of Changes
Other Study ID Numbers: CCD-0903-PR-0060
2011-002060-24 ( EudraCT Number )
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Albuterol
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents