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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00288379

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: formoterol Drug: budesonide/formoterol	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Estimated Enrollment:	16
Study Start Date:	October 2004
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288379

Locations

Sweden
Research Site
Stockholm, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00288379 History of Changes
Other Study ID Numbers:	D5890L00007, EudraCT No 2004-000211-26
Study First Received:	February 7, 2006
Last Updated:	January 21, 2011
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Asthma
allergen challenge
airway responsiveness
airway inflammation
Symbicort®

Additional relevant MeSH terms:

Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Budesonide
Formoterol
Symbicort
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on February 09, 2012