AsthmaPhase 3PAED2/FRESHNCT01475032
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
A Phase 3 study testing CHF 1535, Beclomethasone (BDP) and Beclomethasone (BDP) + Formoterol Fumarate (FF) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 11 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF 1535, Beclomethasone (BDP) and Beclomethasone (BDP) + Formoterol Fumarate (FF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Sep 2011to Sep 2012
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
Slovakia1 site
NZZ- Detská pneumologická a ftizeologická ambulanci
Dolný Smokovec, 059 81
About this study
Official 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
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.
- Conditions
- Asthma
- Being tested
- CHF 1535, Beclomethasone (BDP), Beclomethasone (BDP) + Formoterol Fumarate (FF)
- Keywords
- Asthma, children, chronic treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 1535Drug
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
| Study group | Role | What they receive |
|---|---|---|
| CHF 1535 | Experimental | CHF 1535 (BDP/FF) for 12 weeks Receives: Drug: CHF 1535 |
| BDP | Active comparator | BDP for 12 weeks Receives: Drug: Beclomethasone (BDP) |
| BDP+FF | Active comparator | free combo BDP+FF for 12 weeks Receives: Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-dose FEV1 (forced expiratory volume in the first second)
Assessment of lung function parameter as pre-dose FEV1
Measured: 12 weeks
Secondary outcomes (8)
Patient with Asthma symptoms
Patients with Asthma symptoms
Measured: 12 weeks
FVC (forced vital capacity)
Assessment of lung function parameter as FVC
Measured: 12 weeks
Rescue medication use
rescue medication used by the patient
Measured: 12 weeks
PEF (peak expiratory flow)
Assessment of PEF as lung function parameter
Measured: 12 weeks
Number of patients with adverse events
number of adverse event per patient
Measured: 12 weeks
Blood parameters
Assessment of standard blood parameters (Hematology and chemistry)
Measured: at week 0 and week 12
Heart rate
Assessment of heart rate
Measured: 12 weeks
Blood pressure
Assessment of blood pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugenio BARALDI, MD, Principal investigator, University of Padova - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475032
- Sponsor's protocol ID
- CCD-0807-PR-0024
- Other IDs
- 2009-016757-18, 2009
- Acronym
- PAED2/FRESH
- Status last verified
- Mar 2017
- First submitted
- 11 Oct 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- 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
- ClinicalTrials.gov ID
- NCT01475032
- Acronym / sponsor ID
- PAED2/FRESH / CCD-0807-PR-0024
- Conditions
- Asthma
- Keywords
- Asthma, children, chronic treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Nov 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF 1535 | Experimental | Drug: CHF 1535CHF 1535 (BDP/FF) for 12 weeks |
| BDP | Active comparator | Drug: Beclomethasone (BDP)BDP for 12 weeks |
| BDP+FF | Active comparator | Drug: Beclomethasone (BDP) + Formoterol Fumarate (FF)free combo BDP+FF for 12 weeks |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| CHF 1535CHF 1535 (BDP/FF) for 12 weeks | Drug | CHF 1535 |
| Beclomethasone (BDP)Beclomethasone (BDP) for 12 weeks | Drug | BDP |
| Beclomethasone (BDP) + Formoterol Fumarate (FF)free combo Beclomethasone (BDP) + FF for 12 weeks | Drug | BDP+FF |
Primary outcome
pre-dose FEV1 (forced expiratory volume in the first second)
Time frame: 12 weeks
Assessment of lung function parameter as pre-dose FEV1
8 secondary outcomes
Patient with Asthma symptoms
Time frame: 12 weeks
FVC (forced vital capacity)
Time frame: 12 weeks
Rescue medication use
Time frame: 12 weeks
PEF (peak expiratory flow)
Time frame: 12 weeks
Number of patients with adverse events
Time frame: 12 weeks
Blood parameters
Time frame: at week 0 and week 12
Heart rate
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
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.
- 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.
Eugenio BARALDI, MD principal investigator
University of Padova - Italy
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHF 1535, Beclomethasone (BDP) and Beclomethasone (BDP) + Formoterol Fumarate (FF) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 11 sites in 11 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 4 inclusion and 7 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 11 sites in Bulgaria, France, Germany, Hungary, Italy and 6 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
pre-dose FEV1 (forced expiratory volume in the first second) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.