Symbicort Onset of Action 1

NCT ID: NCT00646620

Last Updated: 2009-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2003-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

budesonide/formoterol

Group Type EXPERIMENTAL

budesonide/formoterol (Symbicort)

Intervention Type DRUG

2

fluticasone/salmeterol

Group Type ACTIVE_COMPARATOR

fluticasone/salmeterol (Advair Diskus)

Intervention Type DRUG

3

albuterol

Group Type ACTIVE_COMPARATOR

albuterol (Ventolin)

Intervention Type DRUG

Interventions

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budesonide/formoterol (Symbicort)

Intervention Type DRUG

fluticasone/salmeterol (Advair Diskus)

Intervention Type DRUG

albuterol (Ventolin)

Intervention Type DRUG

Other Intervention Names

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Symbicort Advair Diskus Ventolin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Catherine Bonuccelli

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D5896C00732

Identifier Type: -

Identifier Source: secondary_id

SD-039-0732

Identifier Type: -

Identifier Source: org_study_id

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