Back to resultsTo Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Terbutaline Turbuhaler®
Salbutamol pMDI
pMDI placebo pMDI
Placebo Turbuhaler®
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Terbutaline, Turbuhaler, Efficacy, Asthma, Japanese, salbutamol, Bricanyl
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
percent of pre-dose (ratio)
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
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
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 to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01096017
Brief Title
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Terbutaline, Turbuhaler, Efficacy, Asthma, Japanese, salbutamol, Bricanyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
Arm Title
2
Arm Type
Experimental
Arm Description
salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Intervention Type
Drug
Intervention Name(s)
Terbutaline Turbuhaler®
Other Intervention Name(s)
Bricanyl Turbuhaler
Intervention Description
0.4 mg, inhalation, single dose
Intervention Type
Drug
Intervention Name(s)
Salbutamol pMDI
Other Intervention Name(s)
Saltanol
Intervention Description
200 μg, inhalation, single dose
Intervention Type
Other
Intervention Name(s)
pMDI placebo pMDI
Intervention Description
Placebo pMDI 2 inhalations
Intervention Type
Other
Intervention Name(s)
Placebo Turbuhaler®
Intervention Description
Placebo Turbuhaler 1 inhalation
Primary Outcome Measure Information:
Title
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation
Description
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. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.
Secondary Outcome Measure Information:
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
Description
percent of pre-dose (ratio)
Time Frame
At two visits during a maximum of 15 days
Title
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation
Description
Time to peak measurement of FEV1 (min)
Time Frame
At two visits during a maximum of 15 days
Title
Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation
Description
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
Title
Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
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