SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma

AstraZeneca16 enrolled

Overview

To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

formoterolDRUG

budesonide/formoterolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnosed history of asthma for at least 6 months * Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks. * FEV1 \>70% of predicted normal value (post-bronchodilator value). * Skin prick test positive to pollen, animal dander or house dust mite. Exclusion Criteria: * Any significant respiratory disease, other than asthma. * Upper or lower respiratory tract infection within 4 weeks before inclusion. * Use of: 1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma. 2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening. 3. regular NSAIDs

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

PD20 methacholine (measured as the change using the measurement before and after each treatment period).

Secondary Outcomes

eNO (ppb).

Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:

Total and differential blood cell count

Different Biomarkers

Safety endpoints will be incidence of Serious Adverse Events (SAEs)

Discontinuation due to Adverse Events (DAEs).

Data from ClinicalTrials.gov

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