Symbicort Onset of Action 1

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00646620

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair Diskus) Drug: albuterol (Ventolin)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Apr 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 budesonide/formoterol	Drug: budesonide/formoterol (Symbicort) Other Names: Symbicort
Active Comparator: 2 fluticasone/salmeterol	Drug: fluticasone/salmeterol (Advair Diskus) Other Names: Advair Diskus
Active Comparator: 3 albuterol	Drug: albuterol (Ventolin) Other Names: Ventolin

Arm

Intervention/Treatment

Experimental: 1

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

Other Names:

Symbicort

Active Comparator: 2

fluticasone/salmeterol

Drug: fluticasone/salmeterol (Advair Diskus)

Other Names:

Advair Diskus

Active Comparator: 3

albuterol

Drug: albuterol (Ventolin)

Other Names:

Ventolin

Outcome Measures

Primary Outcome Measures

FEV1 3 minutes post dose [4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)]

Secondary Outcome Measures

12 hour serial FEV1 [4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)]
Patients perception of effect [4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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