Short- and Long Term Growth in Children With Asthma
Overview[ - collapse ][ - ]
Purpose | 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 |
---|---|
Condition | Asthma |
Intervention | Drug: Budesonide Drug: Montelukast |
Phase | Phase 4 |
Sponsor | Children´s Clinic, Randers |
Responsible Party | Children´s Clinic, Randers |
ClinicalTrials.gov Identifier | NCT00380484 |
First Received | September 25, 2006 |
Last Updated | February 19, 2008 |
Last verified | February 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | September 25, 2006 |
---|---|
Last Updated Date | February 19, 2008 |
Start Date | September 2006 |
Estimated Primary Completion Date | February 2008 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Short- and Long Term Growth in Children With Asthma |
---|---|
Official Title | Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast |
Brief 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 |
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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care |
Condition | Asthma |
Intervention | Drug: Budesonide 200µg daily Drug: Montelukast 5 mg daily Other Names: Singulair |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 52 |
Estimated Completion Date | February 2008 |
Estimated Primary Completion Date | February 2008 |
Eligibility Criteria | Inclusion Criteria: - age 6-11, - prepubertal, - asthma, - normal weight and height, - informed consent Exclusion Criteria: - treatment with systemic/inhaled/intranasal corticosteroids within the last week, - major surgery within 4 weeks, - usage of drugs that significantly inhibit CYP3A4 |
Gender | Both |
Ages | 6 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00380484 |
---|---|
Other Study ID Numbers | BKR-KNAST-06 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Children´s Clinic, Randers |
Study Sponsor | Children´s Clinic, Randers |
Collaborators | Not Provided |
Investigators | Principal Investigator: Ole D Wolthers Children's Clinic Randers |
Verification Date | February 2008 |
Locations[ + expand ][ + ]
Children's Clinic Randers | Randers, Denmark, 8900 |
---|