Conditions: Asthma
Keywords: Terbutaline Turbuhaler Efficacy Asthma Japanese salbutamol Bricanyl
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: no

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:

Arms:
arm 1: Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® arm 2: salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI

Interventions: intervention 1: Terbutaline Turbuhaler® intervention 2: Salbutamol pMDI intervention 3: pMDI placebo pMDI intervention 4: Placebo Turbuhaler®
Intervention descriptions: intervention 1: 0.4 mg, inhalation, single dose intervention 2: 200 μg, inhalation, single dose intervention 3: Placebo pMDI 2 inhalations intervention 4: Placebo Turbuhaler 1 inhalation

Protocol document: