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AsthmaPhase 2PAED3NCT01584492

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

A Phase 2 study testing beclomethasone+formoterol 50/6 (1 inhalation), CHF 1535 50/6 (2 inhalations) and CHF 1535 50/6 (4 inhalations) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 11 years
Conditions the study is for
Asthma
What is being tested?
beclomethasone+formoterol 50/6 (1 inhalation), CHF 1535 50/6 (2 inhalations) and CHF 1535 50/6 (4 inhalations)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
2 sitesin 2 countries
Study dates
Dec 2011to Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Poland1 site

  • Poradnia Alergologiczna

    Dębica, Debica, Poland, 39 -200

Other trials in Poland

Ukraine1 site

  • Zaporizhzhia State Medical University

    Zaporizhzhya, Zaporizhzhia Oblast, 69063

Other trials in Ukraine

About this study

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

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.

Read the 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.

Conditions
Asthma
Being tested
beclomethasone+formoterol 50/6 (1 inhalation), CHF 1535 50/6 (2 inhalations), CHF 1535 50/6 (4 inhalations), Formoterol + Beclomethasone dipropionate, Placebo (6 inhalations)
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • beclomethasone+formoterol 50/6 (1 inhalation)Drug

    Also called CHF1535, Atimos®, Ventolair®, Ventolin®

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

  • CHF 1535 50/6 (2 inhalations)Drug

    Also called CHF1535, Atimos®, Ventolair®, Ventolin®

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

  • CHF 1535 50/6 (4 inhalations)Drug

    Also called CHF1535, Atimos®, Ventolair®, Ventolin®

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

  • Formoterol + Beclomethasone dipropionateDrug

    Also called CHF1535, Atimos®, Ventolair®, Ventolin®

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

  • Placebo (6 inhalations)Drug

    Also called CHF1535, Atimos®, Ventolair®, Ventolin®

    Matched placebo via pMDI

Study groups in NCT01584492
Study groupRoleWhat they receive
Treatment AExperimentalCHF 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
Receives: Drug: beclomethasone+formoterol 50/6 (1 inhalation)
Treatment B:ExperimentalCHF 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
Receives: Drug: CHF 1535 50/6 (2 inhalations)
Treatment CExperimentalCHF 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
Receives: Drug: CHF 1535 50/6 (4 inhalations)
Treatment DActive comparatorformoterol 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
Receives: Drug: Formoterol + Beclomethasone dipropionate
Treatment EPlacebo comparatorplacebo pMDI with spacer, 6 inhalations in the morning at the clinic
Receives: Drug: Placebo (6 inhalations)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: FEV1 AUC measured over 12 hours

Secondary outcomes (1)

  1. dose-related effects of test treatment

    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.

    Measured: Peak FEV1 and FEV1 measured at 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01584492
Sponsor's protocol ID
CCD-0903-PR-0060
Other IDs
2011-002060-24
Acronym
PAED3
Status last verified
Mar 2017
First submitted
23 Apr 2012
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33404895

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing beclomethasone+formoterol 50/6 (1 inhalation), CHF 1535 50/6 (2 inhalations) and CHF 1535 50/6 (4 inhalations) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bronchodilator effect of test treatment (time frame: FEV1 AUC measured over 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01584492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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