Effect of Symbicort on GR Localisation in Asthma
This study has been completed.
Sponsor:
Imperial College London
Collaborator:
AstraZeneca
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159263
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind |
| 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 |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159263
Locations
| United Kingdom | |
| Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital | |
| London, United Kingdom | |
Sponsors and Collaborators
Imperial College London
AstraZeneca
Investigators
| Principal Investigator: | Sergei A Kharitonov, MD PhD | Imperial College London |
More Information
No publications provided by Imperial College London
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00159263 History of Changes |
| Other Study ID Numbers: | BU-039-0005 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013