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

Study Overview
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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).

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Terbutaline Turbuhaler®
* Drug: Salbutamol pMDI
* Other: pMDI placebo pMDI
* Other: Placebo Turbuhaler®


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® | Drug: Terbutaline Turbuhaler®<br>* 0.4 mg, inhalation, single dose<br>* Other names: Bricanyl Turbuhaler;Other: pMDI placebo pMDI<br>* Placebo pMDI 2 inhalations<br>Other: Placebo Turbuhaler®<br>* Placebo Turbuhaler 1 inhalation<br>|
| Experimental: 2<br>salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI | Drug: Salbutamol pMDI<br>* 200 μg, inhalation, single dose<br>* Other names: Saltanol;Other: pMDI placebo pMDI<br>* Placebo pMDI 2 inhalations<br>Other: Placebo Turbuhaler®<br>* Placebo Turbuhaler 1 inhalation<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Terbutaline, Turbuhaler, Efficacy, Asthma, Japanese, salbutamol, Bricanyl