Mild persistent asthma(fulfilling the criteria for asthma of severity grade GINAII) requiring daily maintenance treatment
Conditions
Interventions
Trade Name: Flutide Diskus 100 mikrog
Flutide Diskus 250 mikrog
Flutide Diskus 500 mikrog
Seretide Diskus mite 50/100 mikrog
Seretide Diskus 50/250 mikrog
Seretide Diskus forte 50/500 mikrog
Product N
Sponsors
GlaxoSmithKline AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Visit 1: Subject who are willing to give written informed consent to participate in the study. 2. Males and females ages 18-70 years. 3. Subjects who are able to understand and complete a DRC. 4. Mild persistent asthma according to GINAII as described under "patients" and further developed under additional patient criteria (please see protocol). At randomisation: 1. Day symptoms during run-in more than once a week but not every day. 2. Night symptoms not more than once a week. 3. Lungfunction with FEV1=80% of predicited value before or after a broncho-dilation test. 4. A bronchial variability documented by metacholine reactivity PC20=8mg/ml according to the Juniper-Hargreave method or other validated comparable methods. 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: 1. Changes to regular asthma treatment in the four weeks prior to visit1. 2. Taken oral, depot or parenteral corticosteroids for the treatment of asthma or any other disease within eight weeks of visit 1. 3. Lower respiartory tract infection within four weeks of visit 1. 4. Received any investigational drugs within four weeks of visit 1. 5. Smoking history of 10 pack years. 6. Serious uncontrolled disease likely to interfere with the study. 7. Medical conditions or taking medications that are known to affect the assessment or any of the study endpoints. 8. In the opionon of the investigator evidence of alcohol or drug abuse. 9. Known or planned pregnancy. 10. Known or suspected hypersensitivity to inhaled cortico-steroids, ß2-agonist or lactose. 11. Previously been enrolled into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to compare Seretide Diskus with Flutide Diskus in controlling mild persistent asthma. The protocol allow an increase in treatment during the first six months of the 18 months blinded study as strictly defined in the protocol, i.e. patients not having a good asthma control exactly defined in the protocol increase the treatment successively as needed to stronger formulations of the study medicines. The number of patients in each arm with a need of an increase of study medication is the primary outcome measure.;Secondary Objective: Other important aims include study of change in bronchial hyper-responsiveness (by using metacholine challenge test, which has a high sensitivity and is thus useful when studying mild asthma). Asthma exacerbations including severity of exacerbations and time to first exacerbation will be compared. "Normal" outcome variables include number of symptom free days and nights without use of rescue medication, morning and evening peak flow, diurnal peak-flow variation and FEV1 and FVC as well. Further, quality of life and health economics will be studied.;Primary end point(s): Primary outcomes measure: Number of patients in each arm with a need of an increase of study medication. Secundary outcomes measures: 1. Bronchial hyper-responsiveness, both change from baseline and in absolute values at the end of the study. 2. Number of symptom free days and nights without use of rescue medication. 3. Number of exacerbations; totally, by degree of severity, and by medicine treated exacerbations. 4. Time to first exacerbation; by degree of severity, and by medicine treated exacerbations. 5 Time to increase of study medication. | — |
Countries
Sweden
Outcome results
None listed