NCT00646594

Brief Summary

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Nov 2003

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

November 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.2 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

March 27, 2009

Status Verified

March 1, 2009

First QC Date

March 26, 2008

Last Update Submit

March 26, 2009

Conditions

Asthma

Keywords

Asthmainhaled cortocisteroidsSymbicortbudesonide/formoterolAdvairfluticasone/salmeterol

Outcome Measures

Primary Outcomes (1)

  • Asthma control assessed by asthma exacerbations

    Continuosly throughout the treatment period

Secondary Outcomes (3)

  • Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.

    Daily and at 1, 3 and 6 months after start of treatmen

  • Use of medical resources and medication for the treatment of asthma.

    Throughout the treatment period

  • Investigate safety profile of Symbicort compared to Advair

    1, 3 and 6 months after start of treatment and 1 week after end of tretment

Study Arms (2)

1

EXPERIMENTAL

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

2

ACTIVE COMPARATOR

fluticasone/salmeterol

Drug: fluticasone/salmeterol (Advair)

Interventions

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

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma
  • Baseline lung function tests as determined by protocol
  • Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

You may not qualify if:

  • Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
  • Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PMID: 36472162DERIVED

  • O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154.

    PMID: 20170333DERIVED

MeSH Terms

Conditions

Asthma

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical PreparationsAndrostadienesAndrostenesAndrostanesAlbuterolPhenethylaminesEthylamines

Study Officials

  • Mitchell Golmand, MD

    AstraZeneca

    STUDY DIRECTOR

  • Catherine Bonuccelli

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

November 1, 2003

Study Completion

January 1, 2005

Last Updated

March 27, 2009

Record last verified: 2009-03