A comperative, placebo-controlled, doubleblind, double dummy, cross over, single center phase IIIb study between formoterol alone and the fixed combination of formoterol and budesonide on airway responsiveness and airway inflammation induced by repeated low-dose allergen challenge. - SMILDA
- Conditions
- Patient with stable and mild allergic asthma.
- Registration Number
- EUCTR2004-000211-26-SE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method