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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

beclomethasone+formoterol 50/6 (1 inhalation)

Intervention Type DRUG

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

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

Group Type EXPERIMENTAL

CHF 1535 50/6 (2 inhalations)

Intervention Type DRUG

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

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

Group Type EXPERIMENTAL

CHF 1535 50/6 (4 inhalations)

Intervention Type DRUG

CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer

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

Group Type ACTIVE_COMPARATOR

Formoterol + Beclomethasone dipropionate

Intervention Type DRUG

* Formoterol HFA pMDI 6 µg / actuation
* Extrafine BDP HFA pMDI 50 µg/actuation

Treatment E

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

Group Type PLACEBO_COMPARATOR

Placebo (6 inhalations)

Intervention Type DRUG

Matched placebo via pMDI

Interventions

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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

Intervention Type DRUG

Formoterol + Beclomethasone dipropionate

* Formoterol HFA pMDI 6 µg / actuation
* Extrafine BDP HFA pMDI 50 µg/actuation

Intervention Type DRUG

Placebo (6 inhalations)

Matched placebo via pMDI

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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CHF1535, Atimos®, Ventolair®, Ventolin® CHF1535, Atimos®, Ventolair®, Ventolin® CHF1535, Atimos®, Ventolair®, Ventolin® CHF1535, Atimos®, Ventolair®, Ventolin® CHF1535, Atimos®, Ventolair®, Ventolin®

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No