Symbicort Onset of Action 1

April 3, 2009 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 (Actual)

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:

  • 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 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: Triple

Arms and Interventions

Participant Group / 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

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: 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)

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

April 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2009

Last Update Submitted That Met QC Criteria

April 3, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-039-0732
  • D5896C00732

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.

Clinical Trials on Asthma

Clinical Trials on budesonide/formoterol (Symbicort)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe