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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00288379
First received: February 7, 2006
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  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 3

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
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 June 13, 2013