A Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT, SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 13, 2014
August 1, 2014
1.2 years
February 19, 2009
August 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
asthma control based on GINA guidelines from 2007.
3 months
Secondary Outcomes (1)
Quality of Life, Health economics and exacerbations
3 months
Study Arms (2)
Stable dosing with SERETIDE, short acting B-2agonist as needed
EXPERIMENTALRegular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed
Maintenance treatment with SYMBICORT and SYMBICORT as needed
EXPERIMENTALMaintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed
Interventions
No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations together with a registration of control of asthma in diary cards and health economic parameters in questionnaires
Eligibility Criteria
You may qualify if:
- written informed consent
- years or above
- able to fill in questionnaires and perform PEF measurements
- asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular treatment using SERETIDE in a stable dosing and short acting B2 agonists as needed, or maintenance treatment with SYMBICORT but also using same inhaler SYMBICORT as needed
You may not qualify if:
- no other lung disease
- neurological disease with psychological handicap
- cerebro-vascular disease with handicap
- un-stable cancer
- known or planned pregnancy during the time of the study
- subjects who have serious uncontrolled disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Stockholm, SE-171 77, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2009
First Posted
March 9, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 13, 2014
Record last verified: 2014-08