AsthmaPhase 4NCT00380484
Short- and Long Term Growth in Children With Asthma
A Phase 4 study testing Budesonide and Montelukast in people with Asthma, run by Children´s Clinic, Randers at 1 site in Denmark.
Trial summary
The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide and Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Feb 2008
- Phase
- Phase 4
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 6-11,
- prepubertal,
- asthma,
- normal weight and height,
- informed consent
Who cannot join
- treatment with systemic/inhaled/intranasal corticosteroids within the last week,
- major surgery within 4 weeks,
- usage of drugs that significantly inhibit CYP3A4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma
Read the detailed description
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.
Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.
- Conditions
- Asthma
- Being tested
- Budesonide, Montelukast
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
200µg daily
MontelukastDrug
Also called Singulair
5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Budesonide Receives: Drug: Budesonide |
| 2 | Active comparator | Montelukast Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower leg growth rate
Measured: one year
Height
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children´s Clinic, Randers
- Sponsor type
- University, hospital or other
- Investigators
- Ole D Wolthers, Principal investigator, Children's Clinic Randers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380484
- Sponsor's protocol ID
- BKR-KNAST-06
- Other IDs
- EudractCT-nr 2006-003013-41
- Status last verified
- Feb 2008
- First submitted
- 25 Sep 2006
- Last updated
- 27 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast
- ClinicalTrials.gov ID
- NCT00380484
- Acronym / sponsor ID
- BKR-KNAST-06
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Children´s Clinic, RandersUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 26 Sep 2006 (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 assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma
Detailed description
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.
Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BudesonideBudesonide |
| 2 | Active comparator | Drug: MontelukastMontelukast |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 6-11,
- prepubertal,
- asthma,
- normal weight and height,
- informed consent
Key exclusion criteria (3 listed)
- treatment with systemic/inhaled/intranasal corticosteroids within the last week,
- major surgery within 4 weeks,
- usage of drugs that significantly inhibit CYP3A4
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 |
|---|---|---|
| Budesonide200µg daily | Drug | 1 |
| MontelukastAlso: Singulair5 mg daily | Drug | 2 |
Primary outcome
Lower leg growth rate
Time frame: one year
Height
Time frame: one year
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 27 Feb 2008.
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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.
Ole D Wolthers principal investigator
Children's Clinic Randers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide and Montelukast in people with Asthma, run by Children´s Clinic, Randers 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 5 inclusion and 3 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 27 Feb 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: one year). The study lists 2 primary outcomes in all. 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 27 Feb 2008.