A Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT, SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Spirometry, PEF measurements and diary cards to evaluate control of Asthma (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718
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.
Clinical Details
Official title: Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: asthma control based on GINA guidelines from 2007.
Secondary outcome: Quality of Life, Health economics and exacerbations
Detailed description:
The purpose with this study is to describe in detail the control or lack of control of
asthma, based on two different dosing strategies. No therapy intervention is made with
existing prescribed medications (SERETIDE or SYMBICORT), but evaluations outside standard
care is made by avluations with diary cards, questionnaires, PEF evaluations and spirometry
which is regarded as the intervention by the Swedish Authorities.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- written informed consent
- 18 years or above
- able to fill in questionnaires and perform PEF measurements
- asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular tretament 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
Exclusion Criteria:
- no other lung disease
- neurological disease with psycological handicap
- cerebro-vascular disease with handicap
- un-stable cancer
- known or planned pregnancy during the time ofthe study
- subjects who have serious uncontrolled disease
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718
GSK Investigational Site, STOCKHOLM SE-171 77, Sweden; Recruiting
Additional Information
Starting date: February 2009
Ending date: June 2009
Last updated: May 29, 2009
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