Back to resultsLong-Term Safety of Symbicort in Asthmatic Children - SAPLING
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide/formoterol (Symbicort)
budesonide (Pulmicort)
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
Eligibility Criteria
Inclusion Criteria:
- At least 6 and maximally 11 years of age
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
Exclusion Criteria:
- Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
budesonide/formoterol
budesonide
Outcomes
Primary Outcome Measures
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Secondary Outcome Measures
Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646529
Brief Title
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
Official Title
A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
budesonide/formoterol
Arm Title
2
Arm Type
Active Comparator
Arm Description
budesonide
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol (Symbicort)
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
budesonide (Pulmicort)
Other Intervention Name(s)
Pulmicort
Primary Outcome Measure Information:
Title
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Time Frame
4 assessments within 26 week treatment period
Secondary Outcome Measure Information:
Title
Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Time Frame
4 assessments within 26 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 6 and maximally 11 years of age
Diagnosis of asthma
Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
Exclusion Criteria:
Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Bonuccelli
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
We'll reach out to this number within 24 hrs