Asthma in ChildrenPhase 3NCT01658891
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 combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg and free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg in people with Asthma in Children, run by Chiesi Farmaceutici S.p.A. at 1 site in Denmark.
Trial summary
single center, double-blind, double-dummy, 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
- Asthma in Children
- What is being tested?
- combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg and free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Feb 2016
- 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 < 12 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 NEXThaler® (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
single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
- Conditions
- Asthma in Children
- Being tested
- combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg, free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µgDrug
beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µgDrug
beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CHF 1535 50/6 µg | Experimental | Not described Receives: Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
| beclomethasone dipropionate 100µg + Formoterol fumarate 6µg | Active comparator | Not described Receives: Drug: free combination of beclomethasone dipropionate 100µg + 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 2 weeks of treatment
Secondary outcomes (2)
24-hour urinary free cortisol/creatinine levels
Measured: after 2 weeks of treatment
Changes in pre-dose morning and evening PEF (L/min)
Measured: after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startFeb 2014
- Primary completionNov 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658891
- Sponsor's protocol ID
- CCD-1110-PR-0071
- Status last verified
- Jun 2018
- First submitted
- 3 Aug 2012
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. 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 NEXThaler® (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
- NCT01658891
- Acronym / sponsor ID
- CCD-1110-PR-0071
- Conditions
- Asthma in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Aug 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.
single center, double-blind, double-dummy, 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 50/6 µg | Experimental | Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
| beclomethasone dipropionate 100µg + Formoterol fumarate 6µg | Active comparator | Drug: free combination of beclomethasone dipropionate 100µg + 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 < 12 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 |
|---|---|---|
| combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µgbeclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks | Drug | CHF 1535 50/6 µg |
| free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µgbeclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks | Drug | beclomethasone dipropionate 100µg + Formoterol fumarate 6µg |
Primary outcome
Lower Leg Growth rate measured by Knemometry
Time frame: after 2 weeks of treatment
2 secondary outcomes
24-hour urinary free cortisol/creatinine levels
Time frame: after 2 weeks of treatment
Changes in pre-dose morning and evening PEF (L/min)
Time frame: after 2 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg and free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg in people with Asthma in Children, 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: withdrawn, as of the sponsor's last update on 18 Jun 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 2 weeks of 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 18 Jun 2018.