Effect of Symbicort on GR Localisation in Asthma
Information source: Imperial College London
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Induced Sputum (Procedure); Symbicort, Formoterol, Budesonide and Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Imperial College London Official(s) and/or principal investigator(s):
Sergei A Kharitonov, MD PhD, Principal Investigator, Affiliation: Imperial College London
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.
Clinical Details
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 design: Randomized, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: GR-GRE translocation in induced sputum, exhaled nitric oxide, lung function
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): 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
Locations and Contacts
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital, London, United Kingdom
Additional Information
Starting date: November 2004
Last updated: September 8, 2005
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