A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351143
• Other study ID #: ACE104325
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2006
• Last updated: September 8, 2017
• Start date: July 26, 2005
• Est. completion date: June 13, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: June 13, 2007
• Est. primary completion date: June 13, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
• salmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus C
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Kobenhavn NV
Denmark	GSK Investigational Site	Naestved
Denmark	GSK Investigational Site	Odense C
Switzerland	GSK Investigational Site	Aarau
Switzerland	GSK Investigational Site	Allschwil
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Bever
Switzerland	GSK Investigational Site	Brittnau
Switzerland	GSK Investigational Site	Castione
Switzerland	GSK Investigational Site	Düdingen
Switzerland	GSK Investigational Site	Egg
Switzerland	GSK Investigational Site	Faltigberg-Wald
Switzerland	GSK Investigational Site	Horw
Switzerland	GSK Investigational Site	Klosters
Switzerland	GSK Investigational Site	Malvaglia
Switzerland	GSK Investigational Site	Massagno
Switzerland	GSK Investigational Site	Pregassona
Switzerland	GSK Investigational Site	Steckborn
Switzerland	GSK Investigational Site	Thun
Switzerland	GSK Investigational Site	Wald
Switzerland	GSK Investigational Site	Wigoltingen
Switzerland	GSK Investigational Site	Worb

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects who achieved Total asthma Control: Period 2	Proportion of subjects who achieved Total Control in 7 out of the last 8 consecutive weeks in treatment period 2 with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing and compliance enhancement training compared with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing without compliance enhancement training.	Up to Week 24
Secondary	Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2	Proportion of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing in treatment period 1 will be analyzed.	Up to Week 12
Secondary	Time to first individual week with Total Control	Time to first individual week with Total Control in treatment period 2 will be analyzed.	Up to Week 24
Secondary	Morning peak expiratory flow (PEF)	PEF is defined as a person's maximum speed of expiration and will be measured using a peak flow meter.	Up to Week 24
Secondary	Forced expiratory volume in one second (FEV1)	FEV1 is defined as Forced Expiratory Volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function.	Up to Week 24
Secondary	Asthma symptom score	Asthma symptom score will be analyzed to check the symptom severity	Up to Week 24
Secondary	Number of subjects using rescue medication	Rescue medication usage will be analyzed.	Up to Week 24
Secondary	Number of nights with awakening due to asthma	Number of nights with awakening due to asthma will be analyzed.	Up to Week 24
Secondary	Asthma severity score	Asthma severity score will be analyzed	Up to Week 24
Secondary	Number of subjects with adverse events (AEs)	Adverse events will be observed and counted.	Up to Week 24
Secondary	AQLQ score	Quality of life of subjects with asthma will be analyzed.	Up to Week 24