Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide/formoterol Turbuhaler (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Netherlands Medical Director, MD, Study Director, Affiliation: AstraZeneca
Summary
The primary objective is to compare the effects of Symbicort SiT and treatment according to
NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20
histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).
Clinical Details
Official title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in PD20 histamine
Secondary outcome: number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values
pre-bronchodilator, daily use of inhaled GCS during the last 3 months
Exclusion Criteria:
- Regular need of >4 inhalations of a short-acting b2-agonist/day, known or suspected
hypersensitivity to any of the investigational drugs or inhaled lactose, use of any
b-blocking agent, having smoked ³10 pack-years
Locations and Contacts
Research Site, Appingedam, Netherlands
Research Site, Groningen, Netherlands
Additional Information
Starting date: August 2003
Last updated: March 20, 2007
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