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NCT00272753 Clinical Trial

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00272753
Other study ID # BN-00S-0022
Secondary ID
Status Completed
Phase Phase 4
First received January 4, 2006
Last updated May 31, 2011
Start date April 2004
Est. completion date November 2005

Study information
Verified date May 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• budesonide/formoterol Turbuhaler

• formoterol Turbuhaler

• salbutamol

Locations
Country Name City State
Netherlands Research Site Amsterdam
Netherlands Research Site Groningen

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary The decrease in lung function (FEV1) after the third AMP provocation test.
Secondary Decrease in lung function (FEV1) after the second AMP provocation test,
Secondary lung function and Borg Score over the test day,
Secondary increase in FEV1 at three minutes after study drug inhalation,
Secondary time course of recovery from the AMP-induced decrease in lung function
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