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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096017
• Other study ID #: D589LC00002
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2010
• Last updated: July 27, 2012
• Start date: March 2010
• Est. completion date: April 2010

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Terbutaline Turbuhaler®
0.4 mg, inhalation, single dose
• Salbutamol pMDI
200 µg, inhalation, single dose

Other:
• pMDI placebo pMDI
Placebo pMDI 2 inhalations
• Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation

Locations

Country	Name	City	State
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No