NCT00272753

Brief Summary

The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

2 active sites

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, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

First QC Date

January 4, 2006

Last Update Submit

May 31, 2011

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • The decrease in lung function (FEV1) after the third AMP provocation test.

Secondary Outcomes (4)

  • Decrease in lung function (FEV1) after the second AMP provocation test,

  • lung function and Borg Score over the test day,

  • increase in FEV1 at three minutes after study drug inhalation,

  • time course of recovery from the AMP-induced decrease in lung function

Interventions

budesonide/formoterol TurbuhalerDRUG
Also known as: Symbicort
formoterol TurbuhalerDRUG
salbutamolDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • asthma diagnosis according to ATS criteria,
  • lung function (FEV1) above 60% of predicted,
  • AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test

You may not qualify if:

  • having smoked \> 10 Pack-years,
  • hypersensitivity to one of the study drugs,
  • significant co-morbidity, pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Amsterdam, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Related Publications (1)

  • Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study. Respir Res. 2010 May 28;11(1):66. doi: 10.1186/1465-9921-11-66.

    PMID: 20509942DERIVED

MeSH Terms

Conditions

Asthma

Interventions

BudesonideBudesonide, Formoterol Fumarate Drug CombinationAlbuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsFormoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical PreparationsPhenethylaminesEthylamines

Study Officials

  • AstraZeneca Netherlands Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

NL(2)