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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288379
• Other study ID #: D5890L00007
• Secondary ID: EudraCT No 2004-
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2006
• Last updated: January 21, 2011
• Start date: October 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• A diagnosed history of asthma for at least 6 months

• Mild and stable asthma, only using ß2-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• formoterol

• budesonide/formoterol

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary	eNO (ppb).
Secondary	Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
Secondary	Total and differential blood cell count
Secondary	Different Biomarkers
Secondary	Safety endpoints will be incidence of Serious Adverse Events (SAEs)
Secondary	Discontinuation due to Adverse Events (DAEs).