Asthma
Conditions
Interventions
Product Name: Seretide
Pharmaceutical Form: Inhalation powder
Sponsors
GlaxoSmithKline Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects 18 years of age or above 2) Diagnosed with persistent asthma 3) Treated as an outpatient 4) Treated with up to or equal to 250 mcg fluticasone or up to or equal to 320 mcg budesonide (ex actuator, corresponding to 400 mcg budesonide labelled) b.i.d pre-study (or equivalent for other inhaled corticosteroids) or treated with less than or equal to 50 mcg salmeterol b.i.d pre-study or less than or equal to 9 mcg formoterol (ex actuator, corresponding to 12 mcg labelled formoterol) b.i.d pre-study and/or treated with short acting bronchodilator 5) Non- or ex-smoker (ex-smoker defined as not having smoked during the last year)6) Subjects must give full written, dated, and signed informed consent 7) Female subjects must be post-menopausal, surgically sterile, or using effective contraception (Pearl index > 99). 8) Subject able to comply with the use of the AM2 and the AQLQ in the local language Inclusion criterion for entry into treatment period 2 9) During treatment period 1, subjects must have failed to achieve the criteria for Total control Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria valid for the entire study period 1) Known or suspected Chronic Obstructive Pulmonary Disease (COPD) 2) Pregnant or lactating 3) Participating investigator, employee of an investigator, or family member of any of the aforementioned 4) Smoking history: Pack-years: 10 years or above 5) Have known clinical or laboratory evidence of a serious uncontrolled systemic disease 6) Known hypersensitivity to any substance contained in investigational product or p.r.n medication 7) Participation in a clinical trial with study drug Exclusion criteria for specifically entry into run-in period 8) Treatment with oral corticosteroid within 2 months prior to screening visit 9) Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit 10) Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit 11) Participation in a clinical trial with study drug within 1 month prior to screening visit Exclusion criteria specifically for entry into treatment period 1 12) Changes in asthma medication during the run-in period 13) Treatment with systemic corticosteroids during the run-in period 14) Respiratory tract infection (microbiologically verified) during the run-in period 15) More than one week of Total control prior to baseline visit Exclusion criteria specifically for entry into treatment period 2 16) Changes in asthma medication during the treatment period 1 as listed in protocol section 8.2. 17) Respiratory infection (microbiologically verified) during treatment period 1 18) Total control achieved during treatment period 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the proportion of asthma subjects achieving Total control of their asthma in 7 weeks out of the last 8 consecutive weeks of treatment period 2 when given Seretide Diskus 50/250 mcg b.i.d with compliance enhancement training compared to those given medication alone.;Secondary Objective: •To determine the proportion of subjects who achieved Total control after treat-ment period 1. •To determine the time (weeks) to first ’total control week’ within treatment period 2 dependent on absence or presence of compliance enhancement. •To determine whether there is a difference in the level of quality of life after treatment period 2 dependent on absence or presence of compliance enhancement. •To determine whether there is a difference in the level of compliance with medi-cation dependent on absence or presence of compliance enhancement. •To determine improvement in lung function and symptoms. •To compare asthma severity pre-baseline of the subjects achieving Total control at the end of the study in each treatment group. ;Primary end point(s): The proportion (%) of subjects who achieve ‘Total control’ in 7 out of the last 8 consecutive weeks in treatment period 2 with Seretide Diskus 50/250 mcg fixed dosing and compliance enhancement compared with Seretide Diskus 50/250 mcg fixed dosing without compliance enhancement. | — |
Countries
Denmark
Outcome results
None listed