Study to Investigate the Safety and Efficacy of High Dose of Symbicort SMART in Japanese Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Symbicort Turbuhaler (Drug); Terbutaline Turbuhaler (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Director, Affiliation: AstraZeneca R&D Lund
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
The primary objective of the study is to compare the tolerability of Symbicort Turbuhaler
160/4. 5 μg 10 inhalations with terbutaline Turbuhaler 0. 4 mg 10 inhalations for 3 days on top
of Symbicort Turbuhaler 160/4. 5 μg 1 inhalation bid in adult asthma patients.
Clinical Details
Official title: A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler 0.4 mg on Top of Symbicort Turbuhaler 160/4.5 μg 1 Inhalation Bid, Randomized, Double-Blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
Primary outcome: Adverse events, Clinical laboratory tests, ECG, Vital signs (blood pressure, pulse rate, body temperature)
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- 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 or suspected allergy to study therapy (active drugs or additive)
- 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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Tokyo, Japan; Recruiting
Research Site, Ibaragi, Japan; Recruiting
Additional Information
Starting date: January 2009
Ending date: July 2009
Last updated: February 6, 2009
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