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Trial record 76 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Effect of Symbicort on GR Localisation in 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. Identifier: NCT00159263
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Information provided by:
Imperial College London

Brief Summary:
To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.

Condition or disease Intervention/treatment Phase
Asthma Procedure: Induced Sputum Drug: Symbicort, Formoterol, Budesonide and Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Effect of Symbicort on GR (Glucocorticoid Receptor) Translocation in Induced Sputum in Comparison With Budesonide, Formoterol and Placebo. A Single Dose Exploratory Study in Patients With Mild Asthma
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. GR-GRE translocation in induced sputum, exhaled nitric oxide, lung function

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with mild steroid-naïve asthma (ATS criteria) of either sex with FEV1 >70 % pred
  • Able to produce sputum after sputum induction
  • Exhaled NO (flow 50 ml/s) ≥ 20 ppb
  • Written informed consent

Exclusion Criteria:

  • Current upper respiratory tract infections
  • Use of inhaled and/or oral GCS within 4 weeks prior to visit 1
  • Treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
  • Hypersensitivity to any of the investigational drugs or lactose
  • Use of any -blocking agent (including eye-drops)
  • Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
  • Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
  • Inability to tolerate temporary withdrawal of bronchodilatory therapy
  • Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
  • Previous randomization in this study

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 identifier (NCT number): NCT00159263

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United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Sergei A Kharitonov, MD PhD Imperial College London

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00159263     History of Changes
Other Study ID Numbers: BU-039-0005
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
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