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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
Symbicort Rapihaler Therapeutic Equivalence study - ESTHER
Study identifier:D5897C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily
Medical condition
Bronchial Asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Symbicort Turbuhaler, Symbicort pMDI, Pulmicort Turbuhaler
Sex
All
Actual Enrollment
742
Study type
Interventional
Age
12 Years +
Date
Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Apr 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
PLEVEN, Bulgaria
Location
Research Site
PLOVDIV, Bulgaria
Location
Research Site
Rousse, Bulgaria
Location
Research Site
SOFIA, Bulgaria
Location
Research Site
VARNA, Bulgaria
Location
Research Site
BENESOV U PRAHY, Czech Republic
Location
Research Site
HRADEC KRALOVE, Czech Republic
Location
Research Site
JIHLAVA, Czech Republic
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Symbicort pMDI Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily | Drug: Symbicort pMDI Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Active Comparator: Symbicort Turbuhaler Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily | Drug: Symbicort Turbuhaler Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Active Comparator: Pulmicort Turbuhaler Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily | Drug: Pulmicort Turbuhaler Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 898 subjects enrolled; 156 not randomised: 94 incorrect enrolment, 9 adverse events, 18 voluntary discontinuations, 1 lost to follow-up, 1use of not allowed medication, 1 non-compliant |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Participant Flow: Overall Study
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
| STARTED | 253 | 246 | 243 |
| COMPLETED | 249 | 241 | 238 |
| NOT COMPLETED | 4 | 5 | 5 |
| Adverse Event | 3 | 2 | 3 |
| Withdrawal by Subject | 0 | 2 | 0 |
| Intake of prohibited conc. medication | 0 | 0 | 1 |
| Safety reasons | 0 | 0 | 1 |
| Other | 1 | 1 | 0 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Baseline Measures
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: Participants] |
253 | 246 | 243 | 742 |
| Age Continuous [units: years] Mean ( Full Range ) |
41 (12 to 75) | 42 (12 to 76) | 39 (12 to 78) | 41 (12 to 78) |
| Gender, Male/Female [units: Participants] |
||||
| Female | 152 | 142 | 131 | 425 |
| Male | 101 | 104 | 112 | 317 |
Outcome Measures
1. Primary Outcome Measure: Morning Peak Expiratory Flow (PEF) [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Primary |
|---|---|
| Measure Name | Morning Peak Expiratory Flow (PEF) |
| Measure Description | Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Morning Peak Expiratory Flow (PEF) [units: Liters/min] Mean (Standard Deviation) |
12.88 (24.6) | 13.78 (29.7) | 4.59 (27.9) |
No statistical analysis provided for Morning Peak Expiratory Flow (PEF)
2. Secondary Outcome Measure: Evening Peak Expiratory Flow (PEF) [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Evening Peak Expiratory Flow (PEF) |
| Measure Description | Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Evening Peak Expiratory Flow (PEF) [units: Liters/min] Mean (Standard Deviation) |
12.34 (24.3) | 10.80 (29.1) | 1.43 (25.7) |
No statistical analysis provided for Evening Peak Expiratory Flow (PEF)
3. Secondary Outcome Measure: Asthma Symptom Score, Night [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Asthma Symptom Score, Night |
| Measure Description | Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Asthma Symptom Score, Night [units: Units on a scale] Mean (Standard Deviation) |
-0.24 (0.41) | -0.27 (0.41) | -0.15 (0.39) |
No statistical analysis provided for Asthma Symptom Score, Night
4. Secondary Outcome Measure: Asthma Symptom Score, Day [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Asthma Symptom Score, Day |
| Measure Description | Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Asthma Symptom Score, Day [units: Units on a scale] Mean (Standard Deviation) |
-0.21 (0.38) | -0.24 (0.40) | -0.15 (0.40) |
No statistical analysis provided for Asthma Symptom Score, Day
5. Secondary Outcome Measure: Asthma Symptom Score, Total [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Asthma Symptom Score, Total |
| Measure Description | Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Asthma Symptom Score, Total [units: Units on a scale] Mean (Standard Deviation) |
-0.45 (0.73) | -0.51 (0.75) | -0.30 (0.73) |
No statistical analysis provided for Asthma Symptom Score, Total
6. Secondary Outcome Measure: Percentage of Nights With Awakenings Due to Asthma [ Time Frame: Baseline and 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Percentage of Nights With Awakenings Due to Asthma |
| Measure Description | Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered "Yes" or "No" whether she/he woke up during the night due to asthma. |
| Time Frame | Baseline and 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Percentage of Nights With Awakenings Due to Asthma [units: Percentage of night] Mean (Standard Deviation) |
-14.0 (24.1) | -14.0 (26.4) | -8.3 (25.5) |
No statistical analysis provided for Percentage of Nights With Awakenings Due to Asthma
7. Secondary Outcome Measure: Use of Rescue Medication, Night [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Use of Rescue Medication, Night |
| Measure Description | Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Use of Rescue Medication, Night [units: Inhalations] Mean (Standard Deviation) |
-0.41 (0.64) | -0.39 (0.76) | -0.19 (0.67) |
No statistical analysis provided for Use of Rescue Medication, Night
8. Secondary Outcome Measure: Use of Rescue Medication, Day [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Use of Rescue Medication, Day |
| Measure Description | Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Use of Rescue Medication, Day [units: Inhalations] Mean (Standard Deviation) |
-0.21 (0.39) | -0.20 (0.47) | -0.13 (0.56) |
No statistical analysis provided for Use of Rescue Medication, Day
9. Secondary Outcome Measure: Use of Rescue Medication, Total [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Use of Rescue Medication, Total |
| Measure Description | Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Use of Rescue Medication, Total [units: Inhalations] Mean (Standard Deviation) |
-0.62 (0.89) | -0.58 (1.09) | -0.32 (1.12) |
No statistical analysis provided for Use of Rescue Medication, Total
10. Secondary Outcome Measure: Percentage of Symptom-free Days [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Percentage of Symptom-free Days |
| Measure Description | Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Percentage of Symptom-free Days [units: Percentage of days] Mean (Standard Deviation) |
12.5 (23.7) | 15.3 (24.5) | 9.1 (21.2) |
No statistical analysis provided for Percentage of Symptom-free Days
11. Secondary Outcome Measure: Percentage of Asthma Control Days [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Percentage of Asthma Control Days |
| Measure Description | Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Percentage of Asthma Control Days [units: Percentage of days] Mean (Standard Deviation) |
12.7 (23.6) | 15.1 (24.4) | 9.1 (21.2) |
No statistical analysis provided for Percentage of Asthma Control Days
12. Secondary Outcome Measure: Percentage of Rescue free Days [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Percentage of Rescue free Days |
| Measure Description | Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication. |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 245 | 243 |
| Percentage of Rescue free Days [units: Percentage of days] Mean (Standard Deviation) |
24.0 (30.9) | 26.2 (30.7) | 17.2 (28.4) |
No statistical analysis provided for Percentage of Rescue free Days
13. Secondary Outcome Measure: Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline to 6 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Forced Expiratory Volume in 1 Second (FEV1) |
| Measure Description | Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization) |
| Time Frame | Baseline to 6 weeks |
| Safety Issue? | No |
Population Description
| 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. |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Measured Values
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
253 | 243 | 242 |
| Forced Expiratory Volume in 1 Second (FEV1) [units: Liters] Mean (Standard Deviation) |
0.095 (0.328) | 0.147 (0.364) | 0.112 (0.326) |
No statistical analysis provided for Forced Expiratory Volume in 1 Second (FEV1)
Serious Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort pMDI |
| Symbicort Turbuhaler | Symbicort Turbuhaler |
| Pulmicort Turbuhaler | Pulmicort Turbuhaler |
Serious Adverse Events
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Total, serious adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/253 (0.00%) | 1/246 (0.41%) | 1/243 (0.41%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Asthma1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/253 (0.00%) | 1/246 (0.41%) | 1/243 (0.41%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Symbicort pMDI | Symbicort pMDI |
| Symbicort Turbuhaler | Symbicort Turbuhaler |
| Pulmicort Turbuhaler | Pulmicort Turbuhaler |
Other Adverse Events
| Symbicort pMDI | Symbicort Turbuhaler | Pulmicort Turbuhaler | |
|---|---|---|---|
| Total, other (not including serious) adverse events | |||
| # participants affected / at risk | 0/253 (0.00%) | 0/246 (0.00%) | 0/243 (0.00%) |
Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT 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. |
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact
| Name/Title: | Gerard Lynch |
| Organization: | AstraZeneca |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Tomas Andersson
AstraZeneca
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
