Back to resultsSymbicort Single Inhaler Therapy for Asthma in a General Practice Setting
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
budesonide/formoterol Turbuhaler
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Change in PD20 histamine
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00235911
Brief Title
Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol Turbuhaler
Primary Outcome Measure Information:
Title
Change in PD20 histamine
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Netherlands Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Appingedam
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22015542
Citation
Riemersma RA, Postma D, van der Molen T. Budesonide/formoterol maintenance and reliever therapy in primary care asthma management: effects on bronchial hyperresponsiveness and asthma control. Prim Care Respir J. 2012 Mar;21(1):50-6. doi: 10.4104/pcrj.2011.00090.
Results Reference
derived
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Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
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