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
Completed
Completed
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:
Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2010-22-04
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
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website