A Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT, SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.

Phase 4

Completed

• Conditions: Asthma
• Interventions: Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma

• Registration Number: NCT00858286
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed.

Detailed Description

The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies. No therapy intervention is made with existing prescribed medications (SERETIDE or SYMBICORT), but evaluations outside standard care is made by evluations with diary cards, questionnaires, PEF evaluations and spirometry which is regarded as the intervention by the Swedish Authorities.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-11
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• written informed consent
• 18 years or above
• able to fill in questionnaires and perform PEF measurements
• asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular treatment using SERETIDE in a stable dosing and short acting B2 agonists as needed, or maintenance treatment with SYMBICORT but also using same inhaler SYMBICORT as needed

Exclusion Criteria

• no other lung disease
• neurological disease with psychological handicap
• cerebro-vascular disease with handicap
• un-stable cancer
• known or planned pregnancy during the time of the study
• subjects who have serious uncontrolled disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance treatment with SYMBICORT and SYMBICORT as needed	Spirometry, PEF measurements and diary cards to evaluate control of Asthma	Maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed
Stable dosing with SERETIDE, short acting B-2agonist as needed	Spirometry, PEF measurements and diary cards to evaluate control of Asthma	Regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed

Primary Outcome Measures

Name	Time	Method
asthma control based on GINA guidelines from 2007.	3 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life, Health economics and exacerbations	3 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Stockholm, Sweden