Patient with stable and mild allergic asthma.
Conditions
Interventions
Trade Name: Symbicort Turbuhaler
Product Name: Symbicort Turbuhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Formoterol/Budesonide
Concentration unit: µg microgram(s)
Concentration
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent 2.Female or Male, 18-55 years old. A diagnosed history of asthma for at least 6 months and with at least one of the following: a) response to standard asthma treatment b)episodic wheezing c) change in lung function over short periods of time 3.Mild and stable asthma, only using b2-agonists as needed for the last 4 weeks 4.A FEV1>80% of predicted normal value (postbronchodilator value). 5.Skin prick test positive to pollen, animal dander or house dust mite. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Any significant respiratory disease, other than asthma. 2.Upper or lower respiratory tract infection within 4 weeks before inclusion. 3.Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study. 4.Current or former smoker within the last year and a smoking history of >4 packyears (i.e. equivalent to one pack of 20 cigarettes/day for 4 years). 5.Use of: a) inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma; b) inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theofyllines and antileukotrienes within 2 weeks of screening c) regular NSAIDs 6.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women without acceptable contraceptive measures, as judged by the investigator. 7.BMI >30/kg/m2 8.Participation in another clinical study during the course of the study or within 30 days before enrolment. 9.Conditions associated with poor compliance or alcohol or drug abuse. 10.Previous randomisation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of formoterol alone (Oxis® Turbuhaler®) and the fixed combination of formoterol and budesonide (Symbicort® Turbuhaler®) on airway responsiveness as a marker of inflammation, induced by repeated lowdose allergen challange in allergic patients with mild asthma.;Secondary Objective: To compare the effects of the three treatments on symptoms and lung function, eNO and to assess the effect of repeated low-dose exposure on markers of inflammation in blood and sputum.;Primary end point(s): To assess the effects of formoterol alone (Oxis®) compared to the fixed combination of formoterol and budesonide (Symbicort®) on airway responsiveness, induced by repeated low-dose allergen challenge in allergic patients with mild asthma by assessment of the change in cumulative provocation dose of methacholine causing a 20% decrease in FEV1 (PD20 methacholine). This outcome variable, change in PD20 methacholine, will determin if the primary objective of the study is fulfilled. | — |
Countries
Sweden
Outcome results
None listed