Atlantis Symbicort

Asthma Clinical Trial

Official title:

A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646594
• Other study ID #: D5896C00005
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: March 26, 2009
• Start date: November 2003
• Est. completion date: January 2005

Study information

• Verified date: March 2009
• 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 determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of asthma

• Baseline lung function tests as determined by protocol

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

Exclusion Criteria:

• Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers

• Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide/formoterol (Symbicort)

• fluticasone/salmeterol (Advair)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control assessed by asthma exacerbations		Continuosly throughout the treatment period
Secondary	Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.		Daily and at 1, 3 and 6 months after start of treatmen
Secondary	Use of medical resources and medication for the treatment of asthma.		Throughout the treatment period
Secondary	Investigate safety profile of Symbicort compared to Advair		1, 3 and 6 months after start of treatment and 1 week after end of tretment