Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Terbutaline Turbuhaler; Drug: Symbicort Turbuhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT00837967

D589LC00003

Details and patient eligibility

About

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 twice a day (bid) in adult asthma patients.

Enrollment: 25 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

First Symbicort, then Terbutaline

Experimental group

Description:

Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days

Treatment:

Drug: Symbicort Turbuhaler

Drug: Terbutaline Turbuhaler

First Turbuhaler, then Symbicort

Experimental group

Description:

Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,

Treatment:

Drug: Symbicort Turbuhaler

Drug: Terbutaline Turbuhaler