Childhood AsthmaPhase 3NCT01450774
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
A Phase 3 study testing CHF 1535 50/6µg and beclomethasone dipropionate 50µg + formoterol fumarate 6µg in people with Childhood Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
Trial summary
This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- CHF 1535 50/6µg and beclomethasone dipropionate 50µg + formoterol fumarate 6µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Feb 2014
- 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
- Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
- Clinical diagnosis of mild asthma during at least two months prior to screening visit
- Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit
Who cannot join
- Endocrinological diseases including growth impairment or other chronic diseases
- Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and the Free Combination of Licensed Beclomethasone Dipropionate and Formoterol Fumarate in Asthmatic Children Already Treated With Inhaled Corticosteroids
This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.
- Conditions
- Childhood Asthma
- Being tested
- CHF 1535 50/6µg, beclomethasone dipropionate 50µg + formoterol fumarate 6µg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF 1535 50/6µgDrug
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
beclomethasone dipropionate 50µg + formoterol fumarate 6µgDrug
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
| Study group | Role | What they receive |
|---|---|---|
| CHF 1535 50/6µg | Experimental | Not described Receives: Drug: CHF 1535 50/6µg |
| beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Active comparator | Not described Receives: Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower leg growth rate measured by knemometry
Measured: after a 2 week treatment
Secondary outcomes (2)
24-hour urinary free cortisol/creatinine levels
Measured: after a 2 week treatment period
Changes in pre-dose morning and evening PEF (L/min)
Measured: pre and after a 2 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Bisgaard, MD, Principal investigator, BørneAstmaKlinikken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450774
- Sponsor's protocol ID
- CCD-1012-PR-0051
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and the Free Combination of Licensed Beclomethasone Dipropionate and Formoterol Fumarate in Asthmatic Children Already Treated With Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT01450774
- Acronym / sponsor ID
- CCD-1012-PR-0051
- Conditions
- Childhood Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Oct 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.
This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF 1535 50/6µg | Experimental | Drug: CHF 1535 50/6µg |
| beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Active comparator | Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
- Clinical diagnosis of mild asthma during at least two months prior to screening visit
- Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit
Key exclusion criteria (2 listed)
- Endocrinological diseases including growth impairment or other chronic diseases
- Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids
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 1535 50/6µgfixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Drug | CHF 1535 50/6µg |
| beclomethasone dipropionate 50µg + formoterol fumarate 6µgfree combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Drug | beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
Primary outcome
Lower leg growth rate measured by knemometry
Time frame: after a 2 week treatment
2 secondary outcomes
24-hour urinary free cortisol/creatinine levels
Time frame: after a 2 week treatment period
Changes in pre-dose morning and evening PEF (L/min)
Time frame: pre and after a 2 week treatment period
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.
Hans Bisgaard, MD principal investigator
BørneAstmaKlinikken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHF 1535 50/6µg and beclomethasone dipropionate 50µg + formoterol fumarate 6µg in people with Childhood Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
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 3 inclusion and 2 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 1 site in Denmark. 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?
Lower leg growth rate measured by knemometry (time frame: after a 2 week treatment). 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.