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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® |
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| 2 | Experimental | salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbutaline Turbuhaler® | Drug | 0.4 mg, inhalation, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Andersson, MD | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tokyo | Japan |
37 participants enrolled; 13 excluded (9 due to eligibility criteria not fulfilled and 4 for other reasons)
Participants recruited at one clinic in Tokyo, Japan, between March and April 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Salbutamol First, Then Terbutaline | Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI |
| FG001 | Terbutaline First, Then Salbutamol | Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Salbutamol pMDI | Drug | 200 μg, inhalation, single dose |
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| pMDI placebo pMDI | Other | Placebo pMDI 2 inhalations |
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| Placebo Turbuhaler® | Other | Placebo Turbuhaler 1 inhalation |
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percent of pre-dose (ratio) |
| At two visits during a maximum of 15 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| NOT COMPLETED |
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| Washout 1 - 14 Days |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Geometric Mean | Full Range | milliLiters x minutes | At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes. |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| 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) | Posted | Geometric Mean | Full Range | Percentage of Pre-Dose FEV1 | At two visits during a maximum of 15 days |
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| Secondary | Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation | percent of pre-dose (ratio) | Posted | Geometric Mean | Full Range | Percent change | At two visits during a maximum of 15 days |
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| Secondary | Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation | Time to peak measurement of FEV1 (min) | Posted | Median | Full Range | Minutes | At two visits during a maximum of 15 days |
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| 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. | Posted | Number | Participants | At two visits during a maximum of 15 days |
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| 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 | Posted | Mean | Standard Deviation | Minutes | At two visits during a maximum of 15 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salbutamol pMDI | 200 μg, inhalation, single dose. | 0 | 23 | 0 | 23 | ||
| EG001 | Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose. | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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