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

A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288379

Enrollment

Registered

2006-02-08

Start date

2004-10-31

Completion date

2006-05-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®

Brief summary

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

Interventions

DRUGformoterol

DRUGbudesonide/formoterol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:	—
Total and differential blood cell count	—
eNO (ppb).	—
Safety endpoints will be incidence of Serious Adverse Events (SAEs)	—
Discontinuation due to Adverse Events (DAEs).	—
Different Biomarkers	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026