Asthma
Conditions
Interventions
Trade Name: Seretide Diskus 50/250mcg/dose
Product Name: Seretide Diskus 50/250mcg/dose
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Salmeterol xinofoate
Concentration u
Sponsors
GlaxoSmithKline SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in the run-in period only if all of the following inclusion criteria apply: • Male or female subjects > 18 years • Subjects with a documented history of asthma for a period of at least 6 months • Subjects with a PC20 methacholine 70% at Visit 1 • Subjects who have received fluticasone proprionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose. • Subjects who are able to use a Mini Wright peakflow meter • Subjects who are able to use a DISKUS™ inhaler • Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 70% • Subjects must have recorded data on > 80% of daily entries into their eDRC throughout the run-in period • If subject is of child bearing potential, a negative pregnancy urine test must be performed. 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: A subject will not be eligible for inclusion in this study if any of the following criteria are met: • Subjects who have been hospitalised for their asthma within 4 weeks of Visit 1 • Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1 • Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to Visit 1 • Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function • Subjects who have received any investigational drugs within 4 weeks of Visit 1 • Subjects with a known or suspected hypersensitivity to inhaled steroids, ß2-agonists or lactose • Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole • Subjects who concurrently participate in another clinical study • Subjects who have previously been randomised in this study • Smoking history: Subjects who have more than 5 pack years • Subjects who currently smoke Subjects will be excluded from participating in the treatment period of the study if the following, in addition to the exclusion criteria for entry into the run-period, occurred during the run-in period: • Any change in their run-in asthma medication • Non-compliance with the completion of the eDRC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate whether there is a reduction in airway hyper-responsiveness (assessed by PC20 methacholine) attained as a result of using a treatment strategy of aiming for ‘Total control’ compared to a treatment based on maintaining the treatment level at which ‘Well-controlled’ asthma was achieved. ;Secondary Objective: ;Primary end point(s): The primary endpoint of this study is: Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment | — |
Countries
Belgium, Estonia, Finland, Germany, Italy, Latvia, Spain, Sweden
Outcome results
None listed