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Completed

NCT Number: NCT01475032

Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children

The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMHAT "Alexandrovska, Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female children (aged ≥ 5 and < 12 years)
  • Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
  • Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
  • FEV1 ≥ 60% and ≤ 95% of predicted normal values

Exclusion criteria

  • Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
  • Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
  • History of near fatal asthma
  • History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
  • Diagnosis of restrictive lung disease.
  • Patients treated with systemic corticosteroids
  • Significant medical history and/or treatments

Treatment and study plan

CHF 1535

Drug

CHF 1535 (BDP/FF) for 12 weeks

Beclomethasone (BDP)

Drug

Beclomethasone (BDP) for 12 weeks

Beclomethasone (BDP) + Formoterol Fumarate (FF)

Drug

free combo Beclomethasone (BDP) + FF for 12 weeks

Primary outcomes

  1. pre-dose FEV1 (forced expiratory volume in the first second)

    Time frame: 12 weeks

    Assessment of lung function parameter as pre-dose FEV1

Secondary outcomes

  1. Patient with Asthma symptoms

    Time frame: 12 weeks

    Patients with Asthma symptoms

  2. FVC (forced vital capacity)

    Time frame: 12 weeks

    Assessment of lung function parameter as FVC

  3. Rescue medication use

    Time frame: 12 weeks

    rescue medication used by the patient

  4. PEF (peak expiratory flow)

    Time frame: 12 weeks

    Assessment of PEF as lung function parameter

  5. Number of patients with adverse events

    Time frame: 12 weeks

    number of adverse event per patient

  6. Blood parameters

    Time frame: at week 0 and week 12

    Assessment of standard blood parameters (Hematology and chemistry)

  7. Heart rate

    Time frame: 12 weeks

    Assessment of heart rate

  8. Blood pressure

    Time frame: 12 weeks

    Assessment of blood pressure

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children

Acronym: PAED2/FRESH

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 21, 2011
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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