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.
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.
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- 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
Ukraine1 site
Zaporizhzhia State Medical University
Zaporizhzhya, Zaporizhzhia Oblast, 69063
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Formoterol + Beclomethasone dipropionate |
| Treatment E | Placebo comparator | placebo 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.
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)
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.
- First posted25 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Pohunek, M.D., Principal investigator, Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01584492
- Acronym / sponsor ID
- PAED3 / CCD-0903-PR-0060
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: beclomethasone+formoterol 50/6 (1 inhalation)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 |
| Treatment B: | Experimental | Drug: CHF 1535 50/6 (2 inhalations)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 |
| Treatment C | Experimental | Drug: CHF 1535 50/6 (4 inhalations)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 |
| Treatment D | Active comparator | Drug: Formoterol + Beclomethasone dipropionateformoterol 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 |
| Treatment E | Placebo comparator | Drug: Placebo (6 inhalations)placebo pMDI with spacer, 6 inhalations in the morning at the clinic |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone+formoterol 50/6 (1 inhalation)Also: 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 | Drug | Treatment A |
| CHF 1535 50/6 (2 inhalations)Also: 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 | Drug | Treatment B: |
| CHF 1535 50/6 (4 inhalations)Also: 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 | Drug | Treatment C |
| Formoterol + Beclomethasone dipropionateAlso: CHF1535, Atimos®, Ventolair®, Ventolin®* Formoterol HFA pMDI 6 µg / actuation * Extrafine BDP HFA pMDI 50 µg/actuation | Drug | Treatment D |
| Placebo (6 inhalations)Also: CHF1535, Atimos®, Ventolair®, Ventolin®Matched placebo via pMDI | Drug | Treatment E |
Primary outcome
bronchodilator effect of test treatment
Time frame: FEV1 AUC measured over 12 hours
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.
1 secondary outcome
dose-related effects of test treatment
Time frame: Peak FEV1 and FEV1 measured at 12 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 33404895Pohunek 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Pohunek, M.D. principal investigator
Charles University, 2nd Medical Faculty and University Hospital Motol - CZECH REPUBLIC
2 sites in 2 countries: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.