Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
NCT ID: NCT00837967
Last Updated: 2012-08-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2009-01-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
First Symbicort, then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
Symbicort Turbuhaler
160/4.5μg for 3 days
Terbutaline Turbuhaler
0.4 mg for 3 days
First Turbuhaler, then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
Symbicort Turbuhaler
160/4.5μg for 3 days
Terbutaline Turbuhaler
0.4 mg for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Symbicort Turbuhaler
160/4.5μg for 3 days
Terbutaline Turbuhaler
0.4 mg for 3 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
* FEV1\> 70% of predicted normal value pre-bronchodilator
Exclusion Criteria
* Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
* Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
* Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
16 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tomas Andersson, MD
Role: STUDY_DIRECTOR
AstraZeneca R&D Lund
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Ibaraki, , Japan
Research Site
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D589LC00003
Identifier Type: -
Identifier Source: org_study_id