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 compli-ance enhancement training compared to those receiving medica-tion only.

• Conditions: Asthma

• Registration Number: EUCTR2005-000374-48-DK
• Lead Sponsor: GlaxoSmithKline Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified