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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Terbutaline Turbuhaler®; Drug: Salbutamol pMDI; Other: pMDI placebo pMDI; Other: Placebo Turbuhaler®

• Registration Number: NCT01096017
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-10-03
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Results First Posted: 2012-08-31
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Terbutaline Turbuhaler®	Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
1	pMDI placebo pMDI	Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
1	Placebo Turbuhaler®	Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
2	Salbutamol pMDI	salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
2	pMDI placebo pMDI	salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
2	Placebo Turbuhaler®	salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI

Primary Outcome Measures

Name	Time	Method
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (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.	FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan