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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01096017

First received: March 19, 2010

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 19, 2010

Last Updated Date

July 27, 2012

Start Date ^ICMJE

March 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes. ] [ Designated as safety issue: No ]

FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation

Original Primary Outcome Measures ^ICMJE

FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01096017 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
percent of pre-dose (ratio)
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
percent of pre-dose (ratio)
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
percent of pre-dose (ratio)
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation

Original Secondary Outcome Measures ^ICMJE

% change in FEV1 before and 5, 15, 30, 60, 120, 180 and 240 minutes after inhalations of study drug. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]
Maximum % change in FEV1 within 4 hours after drug inhalation. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]
Time to peak FEV1 within 4 hours after drug inhalation. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]
Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]
Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation. [ Time Frame: At two visits during a maximum of 15 days, where the second visit can take place more than one day, but not more than 14 days after the first visit. ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Terbutaline Turbuhaler®
0.4 mg, inhalation, single dose

Other Name: Bricanyl Turbuhaler
Drug: Salbutamol pMDI
200 μg, inhalation, single dose

Other Name: Saltanol
Other: pMDI placebo pMDI
Placebo pMDI 2 inhalations
Other: Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation

Study Arm (s)

Experimental: 1
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
Interventions:
- Drug: Terbutaline Turbuhaler®
- Other: pMDI placebo pMDI
- Other: Placebo Turbuhaler®
Experimental: 2
salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Interventions:
- Drug: Salbutamol pMDI
- Other: pMDI placebo pMDI
- Other: Placebo Turbuhaler®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01096017

Other Study ID Numbers ^ICMJE

D589LC00002

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Tomas Andersson, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top