Back to resultsNew Version Pulmicort Turbuhaler USA Children
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Pulmicort, Children, Paediatrics, budesonide, Flexhaler
Eligibility Criteria
Inclusion Criteria:
- Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
- A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
- Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.
Exclusion Criteria:
- Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
- Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
- Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
Sites / Locations
Outcomes
Primary Outcome Measures
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Secondary Outcome Measures
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Incidence of Adverse Events
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642161
Brief Title
New Version Pulmicort Turbuhaler USA Children
Official Title
A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Pulmicort, Children, Paediatrics, budesonide, Flexhaler
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
budesonide
Other Intervention Name(s)
Pulmicort
Primary Outcome Measure Information:
Title
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Time Frame
Week 2, 4 and 8, then at week 12
Secondary Outcome Measure Information:
Title
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Time Frame
Week 2, 4 and 8, then at week 12
Title
Incidence of Adverse Events
Time Frame
Week 2, 4 and 8, then at week 12
Title
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Time Frame
6 or 12 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.
Exclusion Criteria:
Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertil Andersson
Organizational Affiliation
AstraZeneca employee
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lars-Göran Carlsson
Organizational Affiliation
AstraZeneca employee
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
New Version Pulmicort Turbuhaler USA Children
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