NCT01475032

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3 asthma

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

October 11, 2011

Last Update Submit

March 28, 2017

Conditions

Asthma

Keywords

Asthmachildrenchronic treatment

Outcome Measures

Primary Outcomes (1)

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

    Assessment of lung function parameter as pre-dose FEV1

    12 weeks

Secondary Outcomes (8)

  • Patient with Asthma symptoms

    12 weeks

  • FVC (forced vital capacity)

    12 weeks

  • Rescue medication use

    12 weeks

  • PEF (peak expiratory flow)

    12 weeks

  • Number of patients with adverse events

    12 weeks

  • +3 more secondary outcomes

Study Arms (3)

CHF 1535

EXPERIMENTAL

CHF 1535 (BDP/FF) for 12 weeks

Drug: CHF 1535

BDP

ACTIVE COMPARATOR

BDP for 12 weeks

Drug: Beclomethasone (BDP)

BDP+FF

ACTIVE COMPARATOR

free combo BDP+FF for 12 weeks

Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)

Interventions

CHF 1535DRUG

CHF 1535 (BDP/FF) for 12 weeks

CHF 1535
Beclomethasone (BDP)DRUG

Beclomethasone (BDP) for 12 weeks

BDP
Beclomethasone (BDP) + Formoterol Fumarate (FF)DRUG

free combo Beclomethasone (BDP) + FF for 12 weeks

BDP+FF

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UMHAT "Alexandrovska

Plovdiv, 4002, Bulgaria

Location

Necker Enfants Malades Hospital

Paris, 75015, France

Location

Drez. Gelb & Knecht

Bretten, 75015, Germany

Location

Micro Care Kft

Szigetvár, 7900, Hungary

Location

G.Gaslini Institute

Genoa, 16147, Italy

Location

Uniwersytetu Medycznego

Lodz, 22 90-153, Poland

Location

Spitalul Clinic Universitar de Urgenta Elias

Bucharest, 011461, Romania

Location

Moscow State Medical University

Moscow, 119435, Russia

Location

NZZ- Detská pneumologická a ftizeologická ambulanci

Dolný Smokovec, 059 81, Slovakia

Location

Hospital de Sabadell

Barcelona, Spain

Location

Institute of Pediatrics

Kyiv, 04050, Ukraine

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasonealpha-ketoisovalerate dehydrogenase phosphataseFormoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Eugenio BARALDI, MD

    University of Padova - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

November 21, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

SL(1)HU(1)DE(1)RO(1)RU(1)IT(1)BU(1)PL(1)ES(1)FR(1)UA(1)