Moderate and severe persistent asthma. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Seretide Diskus mite inhalationpowder pre-dispensed(50/100 mikrog)
Seretide Diskus inhalationpowder pre-dispensed (50/250 mikrog)
Seretide Diskus forte inhalationpowder pre-dispensed(50
Sponsors
GlaxoSmithKline AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females using combination treatment with inhaled corticosteroids and long-acting beta-agonists (Seretide) following a regular stable dosing regimen or patients using a similar combination treatment (Symbicort) but following a symptom based “as needed” regimen”. To be included in the study, patients must have been prescribed to take medicines in any of these two regimens. No changes will be made to the treatments in the study. Subjects must have given written informed consent to participate in the study at visit 1. Subjects must be able to understand and complete daily diary card during three months, able to complete quality of life questionnaires and able to use a PEF-meter. Subjects must be able to attend a visit to the clinic three months after visit 1. 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: Poor compliance completing the daily diary card and/or the quality of life questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to exemplify in detail the control or lack of control of asthma based on two different regimens. The two regimens are; regular treatment using stable dosing of Seretide (one dose morning and evening) or a symptom based “as needed” regimen, Symbicort, allowing changes in the use of maintenance medicines. The primary end-point is a composite of day and night symptoms scoring, morning and evening PEF, daily PEF variability, need of rescue medication and exacerbation of asthma. ;Secondary Objective: Other aims are to measure quality of life using SF-36, AQLQ (asthma specific questionnaire) and ACT (Asthma Control Test), disease related direct and indirect costs, total direct and indirect costs, sick leaves due to illness, use of health care resources and lung function. ;Primary end point(s): The main outcome variables is asthma control based on the revised GINA guidelines from 2007, i.e. if the asthmatics are - well controlled, - partly controlled or - uncontrolled. The time periods will be both days and weeks. The level of control is based on a composite of detailed information from the diary cards about - day and night symptoms, - day and night use of rescue medication, morning and evening peak flow - morning and evening peak flow, and further - asthma exacerbations Which also, each of them, are secondary outcome variables. Secondary end-points: - quality of life according to the generic SF-36 questionnaire, - quality of life according to the disease specific Juniper-Guyatt questionnaire, - all health related contacts, total and by grade of severity, i.e. hospitalisations, phone contacts etc. - sick leave in both days and part of days, - asthma related direct and indirect costs, - total direct and indirect costs. | — |
Countries
Sweden
Outcome results
None listed