New Version Pulmicort Turbuhaler USA Children
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.
2 other identifiers
interventional
430
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Nov 2002
Typical duration for phase_3 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedJanuary 24, 2011
January 1, 2011
1.8 years
March 18, 2008
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Week 2, 4 and 8, then at week 12
Secondary Outcomes (3)
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Week 2, 4 and 8, then at week 12
Incidence of Adverse Events
Week 2, 4 and 8, then at week 12
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
6 or 12 hours post dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bertil Andersson
AstraZeneca employee
- STUDY DIRECTOR
Lars-Göran Carlsson
AstraZeneca employee
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
November 1, 2002
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
January 24, 2011
Record last verified: 2011-01