Symbicort Onset of Action 1

Asthma Clinical Trial

Official title:

A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646620
• Other study ID #: SD-039-0732
• Secondary ID: D5896C00732
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: April 3, 2009
• Start date: April 2003
• Est. completion date: September 2003

Study information

• Verified date: April 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 compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of asthma and baseline lung function test results as determined by protocol

• Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion Criteria:

• Severe asthma or asthma markedly affected by seasonal factors

• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide/formoterol (Symbicort)

• fluticasone/salmeterol (Advair Diskus)

• albuterol (Ventolin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 3 minutes post dose		4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary	12 hour serial FEV1		4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary	Patients perception of effect		4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)