NCT00646009

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_3 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

March 26, 2008

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

asthmaadultsSymbicortbudesonide/formoterolAdvair DiskusVentolin

Outcome Measures

Primary Outcomes (1)

  • FEV1 3 minutes post dose

    4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary Outcomes (2)

  • 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

    Patients perception of effect

Study Arms (3)

1

EXPERIMENTAL

budesonide/formoterol

Drug: budesonide/formoterol

2

ACTIVE COMPARATOR

fluticasone/salmeterol

Drug: fluticasone/salmeterol

3

ACTIVE COMPARATOR

albuterol

Drug: albuterol

Interventions

budesonide/formoterolDRUG
Also known as: Symbicort
1
fluticasone/salmeterolDRUG
Also known as: Advair Diskus
2
albuterolDRUG
Also known as: Ventolin
3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug CombinationFluticasone-Salmeterol Drug CombinationAlbuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsSalmeterol XinafoatePhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanes

Study Officials

  • Catherine Bonuccelli

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

March 1, 2003

Study Completion

August 1, 2003

Last Updated

January 24, 2011

Record last verified: 2011-01