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The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Symbicort, then Terbutaline | Experimental | Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days |
|
| First Turbuhaler, then Symbicort | Experimental | Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort Turbuhaler | Drug | 160/4.5μg for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Total number of adverse events | 3 days |
| Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | up to 740 min after start dosing for each treatment day |
| Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | up to 140 min after start dosing for each treatment day |
| Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | up to 740 min after start dosing for each treatment day |
| Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | up to 740 min after start dosing for each treatment day |
| Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Andersson, MD | AstraZeneca R&D Lund | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ibaraki | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22024920 | Derived | Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000. |
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Patients recruited from 2 hospitals in Japan between January 2009 and July 2009. 28 patients enrolled; 25 patients randomized, 3 patients were not randomized (1 due to incorrect enrollment and 2 due to adverse event)
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort First, Then Terbutaline | Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days |
| FG001 | Terbutaline First, Then Symbicort | Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of 7 - 14 Days |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Adverse Events | Total number of adverse events | Posted | Number | adverse events | 3 days |
|
|
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Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
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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 | Symbicort | Symbicort Turbuhaler 160/4.5μg for 3 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Terbutaline Turbuhaler | Drug | 0.4 mg for 3 days |
|
| up to 740 min after start dosing for each treatment day |
| Tokyo |
| Japan |
| NOT COMPLETED |
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|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | Posted | Mean | Standard Deviation | mEq/L | up to 740 min after start dosing for each treatment day |
|
|
|
| Primary | Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | Posted | Mean | Standard Deviation | mg/dLiters | up to 140 min after start dosing for each treatment day |
|
|
|
| Primary | Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | Posted | Mean | Standard Deviation | ms | up to 740 min after start dosing for each treatment day |
|
|
|
| Primary | Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | Posted | Mean | Standard Deviation | mmHg | up to 740 min after start dosing for each treatment day |
|
|
|
| Primary | Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. | Posted | Mean | Standard Deviation | beats/min | up to 740 min after start dosing for each treatment day |
|
|
|
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | Terbutaline | Terbutaline Turbuhaler 0.4 mg for 3 days | 0 | 23 | 15 | 23 |
| Tremor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |