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	Intervention
Asthma	Procedure: Induced Sputum  Drug: Symbicort, Formoterol, Budesonide and Placebo

Further Study Details: 

Primary Outcomes: GR-GRE translocation in induced sputum, exhaled nitric oxide, lung function
Expected Total Enrollment:  10

Ages Eligible for Study:  21 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

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

United Kingdom
      Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital, London,  United Kingdom

Study chairs or principal investigators

Sergei A Kharitonov, MD PhD,  Principal Investigator,  Imperial College London   

Study ID Numbers:  BU-039-0005
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159263
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13