Last updated: 11/04/2018 04:29:18
A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, open label comparative study to determine the proportion of asthma patients on SERETIDE Diskus 50/250 mcg b.i.d. achieving Total Control when given medication and compliance enhancement training compared to those receiving medication only
Trial description: This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
number of subjects who achieved Total asthma Control: Period 2
Timeframe: Up to Week 24
Secondary outcomes:
Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2
Timeframe: Up to Week 12
Time to first individual week with Total Control
Timeframe: Up to Week 24
Morning peak expiratory flow (PEF)
Timeframe: Up to Week 24
Forced expiratory volume in one second (FEV1)
Timeframe: Up to Week 24
Asthma symptom score
Timeframe: Up to Week 24
Number of subjects using rescue medication
Timeframe: Up to Week 24
Number of nights with awakening due to asthma
Timeframe: Up to Week 24
Asthma severity score
Timeframe: Up to Week 24
Number of subjects with adverse events (AEs)
Timeframe: Up to Week 24
AQLQ score
Timeframe: Up to Week 24
Interventions:
Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Drug: salmeterol/fluticasone propionate 50/250 µg
Enrollment:
274
Observational study model:
Not applicable
Primary completion date:
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)
July 2005 to June 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosed with persistent asthma.
- Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
- Known or suspected Chronic Obstructive Pulmonary Disease.
- Pregnant or lactating.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosed with persistent asthma.
- Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
- Female subjects must not be fertile or must use effective contraception.
- Subject must be able to comply with the use of the questionnaires in the local language.
Exclusion criteria:
- Known or suspected Chronic Obstructive Pulmonary Disease.
- Pregnant or lactating.
- Participating investigator, employee of an investigator, or family member of any of the aforementioned.
- Smoking history: Pack-years > 10 years.
- Have known clinical or laboratory evidence of a serious uncontrolled systemic disease.
- Known hypersensitivity to any substance contained in investigational product or as-needed medication.
- Treatment with oral corticosteroid within 2 months prior to the screening visit.
- Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit.
- Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.
Trial location(s)
Location
GSK Investigational Site
Faltigberg-Wald, Switzerland, 8639
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-13-06
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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