NCT01584492

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Dec 2011

Geographic Reach
2 countries

2 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

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

April 23, 2012

Last Update Submit

March 28, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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.

    FEV1 AUC measured over 12 hours

Secondary Outcomes (1)

  • dose-related effects of test treatment

    Peak FEV1 and FEV1 measured at 12 hours post-dose

Study Arms (5)

Treatment A

EXPERIMENTAL

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)

Treatment B:

EXPERIMENTAL

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)

Treatment C

EXPERIMENTAL

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)

Treatment D

ACTIVE COMPARATOR

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

Treatment E

PLACEBO COMPARATOR

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

Drug: Placebo (6 inhalations)

Interventions

beclomethasone+formoterol 50/6 (1 inhalation)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

Also known as: CHF1535, Atimos®, Ventolair®, Ventolin®
Treatment A
CHF 1535 50/6 (2 inhalations)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

Also known as: CHF1535, Atimos®, Ventolair®, Ventolin®
Treatment B:
CHF 1535 50/6 (4 inhalations)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

Also known as: CHF1535, Atimos®, Ventolair®, Ventolin®
Treatment C
Formoterol + Beclomethasone dipropionateDRUG

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

Also known as: CHF1535, Atimos®, Ventolair®, Ventolin®
Treatment D
Placebo (6 inhalations)DRUG

Matched placebo via pMDI

Also known as: CHF1535, Atimos®, Ventolair®, Ventolin®
Treatment E

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Poradnia Alergologiczna

Dębica, Debica, Poland, 39 -200, Poland

Location

Zaporizhzhia State Medical University

Zaporizhzhia, Zaporizhzhia Oblast, 69063, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 33404895DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

BeclomethasoneAlbuterolFormoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Petr Pohunek, M.D.

    Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

UA(1)PL(1)