Adults With Moderate to Severe Asthma
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 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
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Bertil Andersson, Study Director, Affiliation: AstraZeneca
Summary
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
Secondary outcome: Percentage of symptom free daysPercentage of symptom free nights Percentage of symptom free 24-hours
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Additional Information
Starting date: April 2003
Last updated: January 21, 2011
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