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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288379
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Asthma Drug: formoterol Drug: budesonide/formoterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2004
Actual Study Completion Date : May 2006





Primary Outcome Measures :
  1. PD20 methacholine (measured as the change using the measurement before and after each treatment period).

Secondary Outcome Measures :
  1. eNO (ppb).
  2. Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
  3. Total and differential blood cell count
  4. Different Biomarkers
  5. Safety endpoints will be incidence of Serious Adverse Events (SAEs)
  6. Discontinuation due to Adverse Events (DAEs).


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288379


Locations
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Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
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ClinicalTrials.gov Identifier: NCT00288379    
Other Study ID Numbers: D5890L00007
EudraCT No 2004-000211-26
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Asthma
allergen challenge
airway responsiveness
airway inflammation
Symbicort®
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action