Adults With Moderate to Severe Asthma
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide (Drug); Budesonide (Drug); Budesonide (Drug); Budesonide (Drug); Budesonide (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AstraZeneca
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when
given to asthma patients aged 12 years and above.
Official title: A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
Study design: Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Primary outcome: Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
Percentage of symptom free days
Percentage of symptom free nights
Percentage of symptom free 24-hours
Minimum age: 12 Years.
Maximum age: N/A.
- Male or female aged 12 or over who have asthma
- Ability to properly use an electronic diary
- Able and willing to nebulize for up to 20 minutes every morning and evening
- Hospitalised at least one once or required emergency treatment due to asthma in the
previous 6 months
- Planned hospitalisation during the study
- pregnant women or women planning to become pregnant
Locations and Contacts
Starting date: April 2003
Ending date: March 2005
Last updated: March 18, 2008