AsthmaPhase 3NCT00270348
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
A Phase 3 study testing ciclesonide in people with Asthma, run by Sanofi.
Trial summary
The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period The secondary objective is to investigate changes in growth in… Read more about this study
- Who is it for?
- Ages 5 years to 102 months
- Conditions the study is for
- Asthma
- What is being tested?
- ciclesonide
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Sep 2004
- 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 years to 102 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.
Who cannot join
- Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
About this study
Official title: A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 Mg/Day and 200 Mg/Day (Ex-Valve) Administered Once Daily on Growth in Children With Mild Persistent Asthma
The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period
The secondary objective is to investigate changes in growth in terms of bone age (wrist X-ray), and maintenance of asthma control and safety with ciclesonide
- Conditions
- Asthma
- Being tested
- ciclesonide
- Keywords
- Asthma, Safety, Pediatrics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclesonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
Secondary outcomes (1)
Blinded assessment of bone age according to Greulich and Pyle radiographic atlas with wrist X-rays. Subjects monitored for AEs and any events occurring during study. Pulmonary function tests performed to measure FEV1 in liters and % of predicted FEV1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startDec 2000
- Study completionSep 2004
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 SanofiThe 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
- Double blind
- Enrolment
- 450 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270348
- Sponsor's protocol ID
- LTS6159
- Other IDs
- XRP1526B - 343
- Status last verified
- Dec 2005
- First submitted
- 22 Dec 2005
- Last updated
- 28 Dec 2005
- Results posted
- No
Publications
Skoner DP, Maspero J, Banerji D; Ciclesonide Pediatric Growth Study Group. Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma. Pediatrics. 2008 Jan;121(1):e1-14. doi: 10.1542/peds.2006-2206. Epub 2007 Dec 10.
PubMed 18070931
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 Mg/Day and 200 Mg/Day (Ex-Valve) Administered Once Daily on Growth in Children With Mild Persistent Asthma
- ClinicalTrials.gov ID
- NCT00270348
- Acronym / sponsor ID
- LTS6159
- Conditions
- Asthma
- Keywords
- Asthma, Safety, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- Dec 2000
- Study completion
- Sep 2004
- First posted
- 26 Dec 2005 (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 primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period
The secondary objective is to investigate changes in growth in terms of bone age (wrist X-ray), and maintenance of asthma control and safety with ciclesonide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 years to 102 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.
Key exclusion criteria (1 listed)
- Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
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 |
|---|---|---|
| ciclesonide | Drug | – |
Primary outcome
Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
1 secondary outcome
Blinded assessment of bone age according to Greulich and Pyle radiographic atlas with wrist X-rays. Subjects monitored for AEs and any events occurring during study. Pulmonary function tests performed to measure FEV1 in liters and % of predicted FEV1
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 28 Dec 2005.
- Derived from this study: PubMed 18070931Skoner DP, Maspero J, Banerji D; Ciclesonide Pediatric Growth Study Group. Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma. Pediatrics. 2008 Jan;121(1):e1-14. doi: 10.1542/peds.2006-2206. Epub 2007 Dec 10.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciclesonide in people with Asthma, run by Sanofi.
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 1 inclusion and 1 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 28 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data. 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 NCT00270348, 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 28 Dec 2005.