Symbicort Onset of Action 2

January 21, 2011 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosis of asthma and baseline lung function test results as determined by the protocol
  • Required and received inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

  • Severe asthma or asthma that is markedly effected by seasonal factors
  • Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 3 minutes post dose
Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary Outcome Measures

Outcome Measure
Time Frame
12 hour serial FEV1
Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Patients perception of effect
Time Frame: Patients perception of effect
Patients perception of effect

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Catherine Bonuccelli, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-039-0733
  • D5896C00733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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