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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

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2006)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • - 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: formoterol
  • Drug: budesonide/formoterol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 7, 2006)
16
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288379
Other Study ID Numbers  ICMJE D5890L00007
EudraCT No 2004-000211-26
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP