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Effect of Symbicort on GR Localisation in Asthma

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ClinicalTrials.gov Identifier: NCT00159263
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Information provided by:
Imperial College London

September 8, 2005
September 12, 2005
September 12, 2005
November 2004
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GR-GRE translocation in induced sputum, exhaled nitric oxide, lung function
Same as current
No Changes Posted
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Effect of Symbicort on GR Localisation in Asthma
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
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.
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
  • Procedure: Induced Sputum
  • Drug: Symbicort, Formoterol, Budesonide and Placebo
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Essilfie-Quaye S, Ito K, Ito M, Kharitonov SA, Barnes PJ. Comparison of Symbicort® versus Pulmicort® on steroid pharmacodynamic markers in asthma patients. Respir Med. 2011 Dec;105(12):1784-9. doi: 10.1016/j.rmed.2011.08.020. Epub 2011 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
21 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Imperial College London
Principal Investigator: Sergei A Kharitonov, MD PhD Imperial College London
Imperial College London
September 2005

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