To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study

July 27, 2012 updated by: AstraZeneca

A Study to Investigate the Relative Efficacy of Terbutaline Turbuhaler® 0.4 mg and Salbutamol Pressurized Metered Dose Inhaler (pMDI) 200 μg - a Single Blind, Single Dose, Randomized, Crossover, Phase III Study in Japanese Adult Asthma Patients

This is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject population includes Japanese patients (16 years of age or older) with asthma who need treatment with inhaled Glucocorticosteroids (ICS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2
  • Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value pre-bronchodilator
  • Reversible airway obstruction according to reversibility test performed at Visit 2, defined as an increase in Forced Expiratory Volume in 1 Second (FEV1) ≥12% relative baseline at 15-30 minutes after inhalation of in total 400 μg salbutamol

Exclusion Criteria:

  • Treatment with oral, parenteral or rectal GCS (Glucocorticosteroids)within 4 weeks or depot parenteral GCS (Glucocorticosteroids) within 3 months prior to Visit 2.
  • Change in prescribed asthma medication due to exacerbation of asthma within 4 weeks prior to Visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks prior to Visit 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
Drug: Terbutaline Turbuhaler®
0.4 mg, inhalation, single dose
Other Names:
  • Bricanyl Turbuhaler
Other: pMDI placebo pMDI
Placebo pMDI 2 inhalations
Other: Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation
Experimental: 2
salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Other: pMDI placebo pMDI
Placebo pMDI 2 inhalations
Other: Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation
Drug: Salbutamol pMDI
200 μg, inhalation, single dose
Other Names:
  • Saltanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation
Time Frame: At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.
FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation
At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
Time Frame: At two visits during a maximum of 15 days
percent of pre-dose (ratio)
At two visits during a maximum of 15 days
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
Time Frame: At two visits during a maximum of 15 days
Time to peak measurement of FEV1 (min)
At two visits during a maximum of 15 days
Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation
Time Frame: At two visits during a maximum of 15 days
Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.
At two visits during a maximum of 15 days
Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation
Time Frame: At two visits during a maximum of 15 days
Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation
At two visits during a maximum of 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Tomas Andersson, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589LC00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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