Effect of Symbicort on GR Localisation in Asthma

This study has been completed.
Sponsor:
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
  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:

Primary Outcome Measures:
  • GR-GRE translocation in induced sputum, exhaled nitric oxide, lung function

Estimated Enrollment: 10
Study Start Date: November 2004
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014