NCT00646620

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 Apr 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

April 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
4.6 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

April 6, 2009

Status Verified

April 1, 2009

First QC Date

March 26, 2008

Last Update Submit

April 3, 2009

Conditions

Asthma

Keywords

asthmabronchodilatationSymbicortbudesonide/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

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

Study Arms (3)

1

EXPERIMENTAL

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

2

ACTIVE COMPARATOR

fluticasone/salmeterol

Drug: fluticasone/salmeterol (Advair Diskus)

3

ACTIVE COMPARATOR

albuterol

Drug: albuterol (Ventolin)

Interventions

budesonide/formoterol (Symbicort)DRUG
Also known as: Symbicort
1
fluticasone/salmeterol (Advair Diskus)DRUG
Also known as: Advair Diskus
2
albuterol (Ventolin)DRUG
Also known as: Ventolin
3

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

BudesonideFormoterol FumarateBudesonide, Formoterol Fumarate Drug CombinationFluticasoneSalmeterol XinafoateFluticasone-Salmeterol Drug CombinationAlbuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical PreparationsAndrostadienesAndrostenesAndrostanesPhenethylaminesEthylamines

Study Officials

  • Catherine Bonuccelli

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

April 1, 2003

Study Completion

September 1, 2003

Last Updated

April 6, 2009

Record last verified: 2009-04