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

NCT ID: NCT01096017

Last Updated: 2012-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Asthma

Keywords

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Terbutaline Turbuhaler Efficacy Asthma Japanese salbutamol Bricanyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®

Group Type EXPERIMENTAL

Terbutaline Turbuhaler®

Intervention Type DRUG

0.4 mg, inhalation, single dose

pMDI placebo pMDI

Intervention Type OTHER

Placebo pMDI 2 inhalations

Placebo Turbuhaler®

Intervention Type OTHER

Placebo Turbuhaler 1 inhalation

2

salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI

Group Type EXPERIMENTAL

Salbutamol pMDI

Intervention Type DRUG

200 μg, inhalation, single dose

pMDI placebo pMDI

Intervention Type OTHER

Placebo pMDI 2 inhalations

Placebo Turbuhaler®

Intervention Type OTHER

Placebo Turbuhaler 1 inhalation

Interventions

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Terbutaline Turbuhaler®

0.4 mg, inhalation, single dose

Intervention Type DRUG

Salbutamol pMDI

200 μg, inhalation, single dose

Intervention Type DRUG

pMDI placebo pMDI

Placebo pMDI 2 inhalations

Intervention Type OTHER

Placebo Turbuhaler®

Placebo Turbuhaler 1 inhalation

Intervention Type OTHER

Other Intervention Names

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Bricanyl Turbuhaler Saltanol

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Andersson, MD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D589LC00002

Identifier Type: -

Identifier Source: org_study_id