Clinical trial NCT00351143: A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: QoL
Asthma
asthma compliance enhancement
Salmeterol/fluticasone
Total control
SERETIDE
FEV1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: number of subjects who achieved Total asthma Control: Period 2
timeFrame: Up to Week 24
Secondary outcomes:
measure: 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
measure: Time to first individual week with Total Control
timeFrame: Up to Week 24
measure: Morning peak expiratory flow (PEF)
timeFrame: Up to Week 24
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Up to Week 24
measure: Asthma symptom score
timeFrame: Up to Week 24
measure: Number of subjects using rescue medication
timeFrame: Up to Week 24
measure: Number of nights with awakening due to asthma
timeFrame: Up to Week 24
measure: Asthma severity score
timeFrame: Up to Week 24
measure: Number of subjects with adverse events (AEs)
timeFrame: Up to Week 24
measure: AQLQ score
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Aarhus C
country: Denmark
facility: GSK Investigational Site
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Kobenhavn NV
country: Denmark
facility: GSK Investigational Site
city: Naestved
country: Denmark
facility: GSK Investigational Site
city: Odense C
country: Denmark
facility: GSK Investigational Site
city: Aarau
country: Switzerland
facility: GSK Investigational Site
city: Allschwil
country: Switzerland
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Bever
country: Switzerland
facility: GSK Investigational Site
city: Brittnau
country: Switzerland
facility: GSK Investigational Site
city: Castione
country: Switzerland
facility: GSK Investigational Site
city: Düdingen
country: Switzerland
facility: GSK Investigational Site
city: Egg
country: Switzerland
facility: GSK Investigational Site
city: Faltigberg-Wald
country: Switzerland
facility: GSK Investigational Site
city: Horw
country: Switzerland
facility: GSK Investigational Site
city: Klosters
country: Switzerland
facility: GSK Investigational Site
city: Malvaglia
country: Switzerland
facility: GSK Investigational Site
city: Massagno
country: Switzerland
facility: GSK Investigational Site
city: Pregassona
country: Switzerland
facility: GSK Investigational Site
city: Steckborn
country: Switzerland
facility: GSK Investigational Site
city: Thun
country: Switzerland
facility: GSK Investigational Site
city: Wald
country: Switzerland
facility: GSK Investigational Site
city: Wigoltingen
country: Switzerland
facility: GSK Investigational Site
city: Worb
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ulrik CS, Claudius BK, Tamm M, Harving H, Siersted HC, Backer V, Hellquist B, Dahl R, Hogholm A, Johnk IK. Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial. Clin Respir J. 2009 Jul;3(3):161-8. doi: 10.1111/j.1752-699X.2009.00129.x.