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This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Symbicort/inhaler | Active Comparator | Symbicort BA MDI 2x160/4.5 μg twice daily |
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| Symbicort/inhaler | Active Comparator | Symbicort AC pDMI 2x160/4.5 μg twice daily |
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| Budesonide/inhaler | Active Comparator | Budesonide AC pMDI 2x160 μg twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort | Drug | Breath actuated metered dose inhaler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization. | 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg |
| Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization. | Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Expiratory Flow | Recorded morning upon rising and evening before sleep for 14 weeks | |
| Asthma Symptoms Score (Total) | The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Eckerwall, MD | AstraZeneca R&D, Mölndal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntington Beach | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25596138 | Derived | Murphy KR, Dhand R, Trudo F, Uryniak T, Aggarwal A, Eckerwall G. Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. Respir Med. 2015 Feb;109(2):170-9. doi: 10.1016/j.rmed.2014.12.009. Epub 2015 Jan 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort BA MDI | Symbicort BA MDI 2x160/4.5 μg twice daily |
| FG001 | Symbicort pMDI | Symbicort AC pDMI 2x160/4.5 μg twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Symbicort |
| Drug |
Actuation counter pressured metered dose inhaler |
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| Budesonide | Drug | Actuation counter pressured metered dose inhaler |
|
| Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks |
| Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period. | Recorded 6:00 - 11:00 AM for 14 weeks |
| Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period. | Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks |
| Long Beach |
| California |
| United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Rancho Mirage | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Jose | California | United States |
| Research Site | Tallahassee | Florida | United States |
| Research Site | Savannah | Georgia | United States |
| Research Site | River Forest | Illinois | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | Bangor | Maine | United States |
| Research Site | Wheaton | Maryland | United States |
| Research Site | North Dartmouth | Massachusetts | United States |
| Research Site | Columbia | Missouri | United States |
| Research Site | Rolla | Missouri | United States |
| Research Site | Skillman | New Jersey | United States |
| Research Site | North Syracuse | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Collegeville | Pennsylvania | United States |
| Research Site | Lincoln | Rhode Island | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Greenfield | Wisconsin | United States |
| Research Site | Madison | Wisconsin | United States |
| Research Site | Rousse | Bulgaria | Bulgaria |
| Research Site | Sevlievo | Bulgaria | Bulgaria |
| Research Site | Sofia | Bulgaria | Bulgaria |
| Research Site | Varna | Bulgaria | Bulgaria |
| Research Site | Balassagyarmat | Hungary | Hungary |
| Research Site | Budapest | Hungary | Hungary |
| Research Site | Salgótarján | Hungary | Hungary |
| Research Site | Százhalombatta | Hungary | Hungary |
| Research Site | Moscow | Russia | Russia |
| Research Site | Yekaterinburg | Russia | Russia |
| FG002 | Budesonide | Budesonide AC pMDI 2x160 μg twice daily |
| COMPLETED |
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| NOT COMPLETED |
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All Randomized patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort BA MDI | Symbicort BA MDI 2x160/4.5 μg twice daily |
| BG001 | Symbicort pMDI | Symbicort AC pDMI 2x160/4.5 μg twice daily |
| BG002 | Budesonide | Budesonide AC pMDI 2x160 μg twice daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years since asthma diagnosis | Mean | Standard Deviation | Years |
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| % Predicted FEV1 (Visit 2) | Mean | Standard Deviation | % |
| |||||||||||||||
| % Reversibility in FEV1 (Visit 2) | Reversibility is defined as a change of ≥12% in FEV1 from pre-bronchodilator values (for patients ≥12 and <18 years of age), and for patients ≥18 years of age, a change of ≥12% and 200 mL in FEV1 from pre-bronchodilator values. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 - pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100. | Mean | Standard Deviation | % |
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| % Reversibility in FEV1 (Visit 3) | Mean | Standard Deviation | % |
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| Baseline % Predicted FEV1 (Visit 4) | Mean | Standard Deviation | % |
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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 | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization. | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg |
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| Primary | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization. | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg |
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| Secondary | Peak Expiratory Flow | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Mean | Standard Deviation | L/Min | Recorded morning upon rising and evening before sleep for 14 weeks |
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| Secondary | Asthma Symptoms Score (Total) | The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome. | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Mean | Standard Deviation | Asthma score on a scale of 0 to 3 | Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks |
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| Secondary | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period. | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Mean | Standard Deviation | Percentage of days with no awakenings | Recorded 6:00 - 11:00 AM for 14 weeks |
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| Secondary | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period. | Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable). | Posted | Mean | Standard Deviation | Inhalations/24 hrs | Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks |
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'Number of participants in the safety analysis set is (71 for all the group)as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population'
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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 | Budesonide | 0 | 71 | 3 | 71 | |||
| EG001 | Symbicort BA MDI | 0 | 71 | 2 | 71 | |||
| EG002 | Symbicort pMDI | 1 | 71 | 7 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPENDICITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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No. of participants in the safety analysis set is (71 for all the group) as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than less than or equal to 180 days from the date of AZ's request to allow for the filing of a patent app or the taking of such measures as AZ deems appropriate to establish and preserve its proprietary rights in teh material being submitted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Goran Eckerwall, MD | Astrazeneca | aztrial_results_posting@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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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| 18 - <65 years |
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| 65 - <75 years |
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| >= 75 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Week 3 |
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| Week 7 |
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| Week 12 |
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| Treatment Average |
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| The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1. | ANCOVA | ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate. | Estimated Geometric Mean Ratio | 1.01 | 2-Sided | 95 | 0.97 | 1.05 | The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products. | Yes | Non-Inferiority or Equivalence | Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively. |
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