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NCT00642122 Clinical Trial

Adults With Moderate to Severe Asthma

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00642122
Other study ID # SD-004-0764
Secondary ID D5257L00012
Status Completed
Phase Phase 3
First received March 18, 2008
Last updated January 21, 2011
Start date April 2003
Est. completion date December 2004

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 900
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Budesonide
0.5mg once daily
• Budesonide
1mg once daily
• Budesonide
1mg twice daily
• Budesonide
2mg once daily
• Budesonide
4.00mcg twice daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg. Day -14, 1, and every 28 days thereafter
Secondary Percentage of symptom free days Day -14, 1, and every 28 days thereafter
Secondary Percentage of symptom free nights Day -14, 1, and every 28 days thereafter
Secondary Percentage of symptom free 24-hours Day -14, 1, and every 28 days thereafter
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