Status:
COMPLETED
Effect of Symbicort on GR Localisation in Asthma
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
21-60 years
Phase:
NA
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 budes...
Detailed Description
Combination therapy with inhaled corticosteroids (ICS) and long-acting β(2)-adrenergic agonists (LABA) is reported to have superior effects on controlling asthma symptoms to ICS alone; however, there ...
Eligibility Criteria
Inclusion
- 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
- 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 beta 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00159263
Start Date
November 1 2004
End Date
November 1 2006
Last Update
September 27 2019
Active Locations (1)
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1
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom