Last updated: 11/04/2018 11:06:49
Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Asthma control assessment via ACT and DRC in Asthmatics treated with Seretide (50/250) over 12 weeks
Trial description: The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of well controlled participants as per gaining optimal asthma control (GOAL) criteria after 12 week compared to percentage of participants with asthma control test (ACT) score of 20-25 for Week 9 to Week 12
Timeframe: Week 9 to Week 12
Secondary outcomes:
Change from Baseline in percentage of participants with ACT score of 20-25 at Week 12
Timeframe: Baseline (Visit 3) and Week 12
Change from Baseline in mean ACT score at Visit 6
Timeframe: Baseline (Viait 3) and Week 12
Number of participants with well controlled and totally controlled asthma at Week 12
Timeframe: Week 12
Change from Baseline in quality of life using the asthma quality of life questionnaire (AQLQ)
Timeframe: Baseline (Visit 3) up to Week 12
Correlation of change in AQLQ score and change in ACT score
Timeframe: Week 12
Change from Baseline in Forced expiratory volume (FEV1) to Week 12
Timeframe: Baseline (Visit 3) up to Week 12
Change from Baseline in mean morning percent predicted peak expiratory flow (PEF) at Week 12
Timeframe: Baseline (Visit 3) and Week 12
Change from Baseline in mean 24-hour symptom score at Week 12
Timeframe: Baseline (Visit 3) and Week 12
Change from Baseline in number of additional usage of salbutamol at Week 12
Timeframe: Baseline (Visit 3) and week 12
Percent change from Baseline in number of nights with no nocturnal awakening at Week 12
Timeframe: Baseline (Visit 3) and week 12
Number of participants with emergency visits due to asthma
Timeframe: Up to week 12
Number of participants with adverse events (AE) leading to a change in asthma treatment
Timeframe: Up to Week 12
Assessment of tolerability by number of participants with at least one treatment emergent serious and, non-serious AE
Timeframe: Up to Week 12
Assessment of tolerability by change from baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timeframe: Baseline (Visit 3) up to Week 12
Assessment of tolerability by change from baseline of Pulse Rate
Timeframe: Baseline (Visit 3) up to Week 12
Number of Participants with occurrence of (near-) incidents associated with peak flow measurements
Timeframe: Up to Week 12
Interventions:
Drug: Salmeterol/Fluticasone 50/250 mcg
Drug: Salbutamol 100 mcg
Device: DISKUS™ powder inhalers
Enrollment:
221
Observational study model:
Not applicable
Primary completion date:
2007-14-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
May 2006 to September 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of asthma
- Reversibility >12% after inhalation of 200 µg Salbutamol
- Change of asthma medication during the last 4 weeks
- Asthma exacerbation characterized by use of oral corticoids during the last 3 months
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of asthma
- Reversibility >12% after inhalation of 200 µg Salbutamol
- willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
- 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria
Exclusion criteria:
- Change of asthma medication during the last 4 weeks
- Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
- upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
- Non compliance with use of Discus, PEF-meter and incomplete diary card data
Trial location(s)
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Braunschweig, Niedersachsen, Germany, 38100
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Buchholz, Niedersachsen, Germany, 21244
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Uttenreuth, Bayern, Germany, 91080
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Arolsen, Hessen, Germany, 34454
Status
Terminated/Withdrawn
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
2007-14-09
Actual study completion date
2007-14-09
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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