Study identifier:D589LC00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
asthma
Phase 3
No
Terbutaline Turbuhaler®, Salbutamol pMDI
All
24
Interventional
16 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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).
Location
Location
Tokyo, Japan
Arms | Assigned Interventions |
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Experimental: 1 Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® | Drug: Terbutaline Turbuhaler® 0.4 mg, inhalation, single dose Other Name: Bricanyl Turbuhaler Other: pMDI placebo pMDI Placebo pMDI 2 inhalations Other: Placebo Turbuhaler® Placebo Turbuhaler 1 inhalation |
Experimental: 2 salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI | 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 |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Participants recruited at one clinic in Tokyo, Japan, between March and April 2010 |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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37 participants enrolled; 13 excluded (9 due to eligibility criteria not fulfilled and 4 for other reasons) |
Description | |
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Salbutamol First, then Terbutaline | Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI |
Terbutaline First, then Salbutamol | Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler® |
Salbutamol First, then Terbutaline | Terbutaline First, then Salbutamol | |
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STARTED | 12 | 12 |
COMPLETED | 12 | 12 |
NOT COMPLETED | 0 | 0 |
Salbutamol First, then Terbutaline | Terbutaline First, then Salbutamol | |
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STARTED | 12 | 12 |
COMPLETED | 12 | 12 |
NOT COMPLETED | 0 | 0 |
Salbutamol First, then Terbutaline | Terbutaline First, then Salbutamol | |
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STARTED | 12 | 12 |
COMPLETED | 11 | 11 |
NOT COMPLETED | 1 | 1 |
Eligibility criteria not fulfilled | 1 | 1 |
Description | |
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All study participants |
All study participants | |
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Number of Participants
[units: Participants] |
24 |
Age Continuous [units: Years] Mean ± Standard Deviation |
41.7 ± 7.4 |
Gender, Male/Female [units: Participants] |
|
Female | 17 |
Male | 7 |
Measure Type | Primary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 second) Area Under Curve (AUC) 0-4 hours after drug inhalation |
Measure 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. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 second) Area Under Curve (AUC) 0-4 hours after drug inhalation [units: milliLiters x minutes] Geometric Mean (Full Range) |
617.56 (352.57 to 974.45) | 634.64 (356.68 to 1016.46) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 5 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 5 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
115.58 (102.80 to 137.95) | 112.80 (100.00 to 134.85) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 15 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 15 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
118.15 (105.11 to 142.16) | 115.69 (103.27 to 138.59) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 30 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 30 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
119.42 (103.28 to 147.32) | 117.02 (99.59 to 139.83) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 60 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 60 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
120.28 (102.19 to 149.19) | 118.11 (102.86 to 144.40) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 120 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 120 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
119.54 (97.45 to 149.73) | 119.79 (103.27 to 150.21) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 180 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 180 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
116.68 (92.70 to 142.70) | 118.48 (100.68 to 146.06) |
Measure Type | Secondary |
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Measure Name | FEV1 (Forced Expiratory Volume in 1 Second) at 240 minutes after inhalations of study drug as percentage of pre-dose |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Number of
Participants Analyzed [units:participants] |
22 | 22 |
FEV1 (Forced Expiratory Volume in 1 Second) at 240 minutes after inhalations of study drug as percentage of pre-dose [units: Percentage of Pre-Dose FEV1] Geometric Mean (Full Range) |
113.59 (87.96 to 132.67) | 117.05 (97.96 to 139.00) |
Measure Type | Secondary |
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Measure Name | Maximum % change in FEV1 (Forced Expiratory Volume in 1 Second) within 4 hours after drug inhalation |
Measure Description | percent of pre-dose (ratio) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
Maximum % change in FEV1 (Forced Expiratory Volume in 1 Second) within 4 hours after drug inhalation [units: Percent change] Geometric Mean (Full Range) |
122.62 (105.11 to 149.73) | 121.43 (105.31 to 150.21) |
Measure Type | Secondary |
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Measure Name | Time to peak FEV1 (Forced Expiratory Volume in 1 Second) within 4 hours after drug inhalation |
Measure Description | Time to peak measurement of FEV1 (min) |
Time Frame | At two visits during a maximum of 15 days |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
Time to peak FEV1 (Forced Expiratory Volume in 1 Second) within 4 hours after drug inhalation [units: Minutes] Median (Full Range) |
60.00 (5.00 to 180.00) | 120.00 (5.00 to 240.00) |
Measure Type | Secondary |
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Measure Name | Number of patients with % change in FEV1 (Forced Expiratory Volume in 1 Second) >15% within 4 hours after drug inhalation |
Measure 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 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
22 | 22 |
Number of patients with % change in FEV1 (Forced Expiratory Volume in 1 Second) >15% within 4 hours after drug inhalation [units: Participants] |
17 | 16 |
Measure Type | Secondary |
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Measure Name | Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation |
Measure 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 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Number of
Participants Analyzed [units:participants] |
22 | 22 |
Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation [units: Minutes] Mean (Standard Deviation) |
31.36 (37.49) | 34.32 (40.31) |
Time Frame | No text entered. |
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Additional Description | No text entered. |
Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose. |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose. |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Total, serious adverse events | ||
# participants affected / at risk | 0/23 (0.00%) | 0/23 (0.00%) |
Time Frame | No text entered. |
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Additional Description | No text entered. |
Threshold above which other adverse events are reported | 5% |
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Description | |
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Salbutamol pMDI | 200 μg, inhalation, single dose. |
Terbutaline Turbuhaler® | 0.4 mg, inhalation, single dose. |
Salbutamol pMDI | Terbutaline Turbuhaler® | |
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Total, other (not including serious) adverse events | ||
# participants affected / at risk | 0/23 (0.00%) | 0/23 (0.00%) |
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |
Name/Title: | Gerard Lynch |
Organization: | AstraZeneca |
E-mail: | [email protected] |
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