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

NCT00837967 | Completed Phase 3 Results

• 1 other identifier: D589LC00003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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 twice a day (bid) in adult asthma patients.

Conditions

Asthma

Keywords

Asthma; Symbicort Turbuhaler

Outcome Measures

Primary Outcomes (6)

• Adverse Events

  Total number of adverse events

  3 days

• Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)

  The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

  up to 740 min after start dosing for each treatment day

• Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)

  The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

  up to 140 min after start dosing for each treatment day

• Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)

  The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

  up to 740 min after start dosing for each treatment day

• Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)

  The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

  up to 740 min after start dosing for each treatment day

• Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)

  The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

  up to 740 min after start dosing for each treatment day

Study Arms (2)

First Symbicort, then Terbutaline

EXPERIMENTAL

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

Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler

First Turbuhaler, then Symbicort

EXPERIMENTAL

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

Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler

Interventions

Symbicort Turbuhaler DRUG

160/4.5μg for 3 days

First Symbicort, then Terbutaline; First Turbuhaler, then Symbicort

Terbutaline Turbuhaler DRUG

0.4 mg for 3 days

First Symbicort, then Terbutaline; First Turbuhaler, then Symbicort

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Ibaraki, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 22024920 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Tomas Andersson, MD

  AstraZeneca R&D Lund

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 29, 2012
• Results First Posted: August 29, 2012

Record last verified: 2012-08

Locations

JP (2)