AsthmaPhase 4NCT00487773
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
A Phase 4 study testing budesonide, D3 vitamin and montelukast sodium in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide, D3 vitamin and montelukast sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2007to Sep 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Allergic only to house dust mites
- Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs
- Newly-diagnosed or non-treated asthma
- Must be able to inhale drugs
Who cannot join
- Other allergic diseases requiring treatment with glucocorticosteroids
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics and Allergy, Medical University of Lodz
Lodz, 93-513
About this study
Official title: Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.
The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
Read the detailed description
Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
- Conditions
- Asthma
- Being tested
- budesonide, D3 vitamin, montelukast sodium, salbutamol
- Keywords
- asthma, children, inhaled glucocorticosteroids, bone metabolism
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
budesonide
D3 vitaminDrug
D3 vitamin
montelukast sodiumDrug
montelukast sodium
salbutamolDrug
salbutamol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | budesonide Receives: Drug: budesonide |
| 2 | Active comparator | D3 vitamin Receives: Drug: D3 vitamin |
| 3 | Active comparator | montelukast sodium Receives: Drug: montelukast sodium |
| 4 | Active comparator | salbutamol Receives: Drug: salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of bone metabolism (from serum and urine)
Measured: Baseline and 6 months
Secondary outcomes (1)
Symptoms score (based on PAQLQ), spirometry
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Malgorzata Olszowiec-Chlebna, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD, PhD, Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487773
- Sponsor's protocol ID
- RNN-87-06-KE
- Status last verified
- Apr 2010
- First submitted
- 18 Jun 2007
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00487773
- Acronym / sponsor ID
- RNN-87-06-KE
- Conditions
- Asthma
- Keywords
- asthma, children, inhaled glucocorticosteroids, bone metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jun 2007 (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 the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
Detailed description
Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: budesonidebudesonide |
| 2 | Active comparator | Drug: D3 vitaminD3 vitamin |
| 3 | Active comparator | Drug: montelukast sodiummontelukast sodium |
| 4 | Active comparator | Drug: salbutamolsalbutamol |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Allergic only to house dust mites
- Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs
- Newly-diagnosed or non-treated asthma
- Must be able to inhale drugs
Key exclusion criteria (4 listed)
- Other allergic diseases requiring treatment with glucocorticosteroids
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
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 |
|---|---|---|
| budesonidebudesonide | Drug | 1 |
| D3 vitaminD3 vitamin | Drug | 2 |
| montelukast sodiummontelukast sodium | Drug | 3 |
| salbutamolsalbutamol | Drug | 4 |
Primary outcome
Markers of bone metabolism (from serum and urine)
Time frame: Baseline and 6 months
1 secondary outcome
Symptoms score (based on PAQLQ), spirometry
Time frame: baseline and 6 months
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 13 Apr 2010.
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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.
Malgorzata Olszowiec-Chlebna, MD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
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, D3 vitamin and montelukast sodium in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
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 4 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 13 Apr 2010. 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 Poland. 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?
Markers of bone metabolism (from serum and urine) (time frame: Baseline and 6 months). 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 13 Apr 2010.