Last updated: 11/03/2018 10:36:39
A follow-up survey to compare stable dosing (SERETIDE) with SYMBICORT, SMART, maintenance and reliever therapy in one inhaler in moderate and severe asthmatics.N/A
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial 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, 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Asthma control based on revised Global Initiative for Asthma (GINA) guidelines from 2007
Timeframe: Up to 3 months
Secondary outcomes:
Asthma Day and night symptoms
Timeframe: Up to 3 months
Morning and evening peak flow
Timeframe: Up to 3 months
Use of Day and night rescue medication
Timeframe: Up to 3 months
Asthma exacerbations
Timeframe: Up to 3 months
Quality of life according to the generic SF-36 questionnaire
Timeframe: Up to 3 months
Quality of life according to the disease specific Juniper-Guyatt questionnaire
Timeframe: Up to 3 months
All health related contacts, total and by grade of severity, i.e. hospitalizations, phone contacts etc.
Timeframe: Up to 3 months
Sick leave in both days and part of days
Timeframe: Up to 3 months
Asthma related direct and indirect costs
Timeframe: Up to 3 months
Interventions:
Enrollment:
56
Primary completion date:
2010-22-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
February 2009 to April 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- written informed consent
- 18 years or above
- no other lung disease
- neurological disease with psychological handicap
Inclusion and exclusion 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 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
Exclusion criteria:
- 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-22-04
Actual study completion date
2010-22-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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