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Completed

NCT Number: NCT00288379

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
  • inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
  • regular NSAIDs

Treatment and study plan

Formoterol

Drug

budesonide/formoterol

Drug

Primary outcomes

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Feb 8, 2006
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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