NCT00652392

Brief Summary

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Trial Health

100
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Apr 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

April 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

April 1, 2008

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

asthmaadolescentsadultsSymbicortbudesonide/formoterolbudesonide

Outcome Measures

Primary Outcomes (1)

  • Change in evening PEF

    Daily throughout the 12 week treatment period

Secondary Outcomes (3)

  • Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

    Daily throughout the 12 week treatment period

  • Health-related quality of life

    4 assessments within 12 week treatment period

  • Routine safety assessments

    4 assessments within 12 week treatment period

Study Arms (2)

1

EXPERIMENTAL
Drug: budesonide/formoterol

2

PLACEBO COMPARATOR
Drug: budesonide and placebo

Interventions

budesonide/formoterolDRUG
Also known as: Symbicort
1
budesonide and placeboDRUG
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte W. Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma. Allergy Asthma Proc. 2010 Jan-Feb;31(1):49-59. doi: 10.2500/aap.2010.31.3309.

    PMID: 20167145DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug CombinationBudesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

April 1, 2003

Study Completion

June 1, 2004

Last Updated

January 24, 2011

Record last verified: 2011-01