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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Other: Spirometry, PEF measurements and diary cards to evaluate control of Asthma

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858286

109780

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Stable dosing with SERETIDE, short acting B-2agonist as needed

Experimental group

Description:

Regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed

Treatment:

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

Maintenance treatment with SYMBICORT and SYMBICORT as needed

Experimental group

Description:

Maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed

Treatment:

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