Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
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
1 other identifier
interventional
100
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Sep 2003
Longer than P75 for phase_3 asthma
2 active sites
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
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 24, 2011
January 1, 2011
3.1 years
October 7, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in PD20 histamine
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Appingedam, Netherlands
Research Site
Groningen, Netherlands
Related Publications (1)
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.
PMID: 22015542DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Netherlands Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
September 1, 2003
Primary Completion
October 1, 2006
Study Completion
December 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01