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NCT00651768 Clinical Trial

Titratable Dosing in Moderate to Severe Asthmatics

Asthma Clinical Trial

Official title:
A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651768
Other study ID # SD-039-0728
Secondary ID D5896C00728
Status Completed
Phase Phase 3
First received April 1, 2008
Last updated January 21, 2011
Start date August 2003
Est. completion date January 2005

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

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Recruitment information / eligibility
Status Completed
Enrollment 570
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol

- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

- Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.

- Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• budesonide/formoterol

• Symbicort pMDI + budesonide HFA pMDI
Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. 7 assessments within 12 month treatment period
Secondary To measure changes in lung function tests, patient reported outcomes and usage of medical resource 7 assessments within 12 month treatment period
Secondary Blood levels of budesonide and formoterol 10 blood samples taken at 1 visit in a sub-set of patients
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