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

NCT01096017 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	24
Start date	2010-03
Completion	2010-04

Conditions

• Asthma

Interventions

• Terbutaline Turbuhaler®
• Salbutamol pMDI
• pMDI placebo pMDI
• Placebo Turbuhaler®

Primary outcomes

• 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

Countries

Japan