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Completed

NCT Number: NCT00272753

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

budesonide/formoterol Turbuhaler

Drug

Other names: Symbicort

formoterol Turbuhaler

Drug

Salbutamol

Drug

Primary outcomes

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

Secondary outcomes

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

  2. lung function and Borg Score over the test day,

  3. increase in FEV1 at three minutes after study drug inhalation,

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma

Important dates

Study start
2004
Study completion
2005
First posted
Jan 9, 2006
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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