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This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFF MDI 320/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
|
| BFF MDI 160/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
|
| FF MDI 9.6 μg | Experimental | Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID |
|
| BD MDI 320 μg | Experimental | Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
|
| Symbicort® TBH 400/12 μg | Other | Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFF MDI 320/9.6 μg | Drug | Blinded Treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) | Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI) | at Week 24 |
| Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI) | Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period. | at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). | Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI). | over 24 Weeks (timepoints of 4, 12 & 20 weeks) |
| Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Substudy: 12-hour PFT Endpoint FEV1 AUC0-12 | Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Athens | Alabama | 35611 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35815359 | Derived | Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314. | |
| 30220648 | Derived | Ferguson GT, Papi A, Anzueto A, Kerwin EM, Cappelletti C, Duncan EA, Nyberg J, Dorinsky P. Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study. Eur Respir J. 2018 Sep 16;52(3):1801334. doi: 10.1183/13993003.01334-2018. Print 2018 Sep. |
| Label | URL |
|---|---|
| Related Info | View source |
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Subjects were randomized in a 3:3:3:1:1 ratio to BFF 320/9.6, BFF 160/9.6, FF 9.6, BD 320, and Symbicort.
This study randomized subjects at 244 study centers in 7 countries, from June 2016 and November 2017. The study period was scheduled to take up to approximately 30 weeks for each individual subject from the time of screening through the follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | BFF MDI 320/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg |
| FG001 | BFF MDI 160/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2017 | Jan 30, 2019 |
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| BFF MDI 160/9.6 μg | Drug | Blinded Treatment |
|
|
| FF MDI 9.6 μg | Drug | Blinded Treatment |
|
|
| BD MDI 320 μg | Drug | Blinded Treatment |
|
|
| Symbicort® TBH 400/12 μg BID | Drug | Open Label |
|
|
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. |
| at Week 24 |
| Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI) | Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI) | at Week 24 |
| Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI) | Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI) | at Week 24 |
| Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI) | Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI) | over 24 Weeks |
| FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 5 Minutes |
| FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 15 Minutes |
| FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 30 Minutes |
| FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 1 Hour |
| FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 2 Hours |
| FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | Day 1 - 4 Hours |
| at Week 12 |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Research Site | Dothan | Alabama | 36305 | United States |
| Research Site | Phoenix | Arizona | 85006 | United States |
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| Research Site | Edmonton | Alberta | T6L 5X8 | Canada |
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| Research Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7M 4Y1 | Canada |
| Research Site | Greater Sudbury | Ontario | P3A 1W8 | Canada |
| Research Site | Toronto | Ontario | M3J 2C5 | Canada |
| Research Site | Windsor | Ontario | N8X 1T3 | Canada |
| Research Site | Windsor | Ontario | N8X 5A6 | Canada |
| Research Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Research Site | Montreal | Quebec | H1M 1B1 | Canada |
| Research Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Research Site | Québec | Quebec | G1G 3Y8 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Québec | Quebec | G3K 2P8 | Canada |
| Research Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Research Site | Victoriaville | Quebec | G6P 6P6 | Canada |
| Research Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Research Site | Québec | G1W 4R4 | Canada |
| Research Site | Boskovice | 680 01 | Czechia |
| Research Site | Brandýs nad Labem | 250 01 | Czechia |
| Research Site | Jindřichův Hradec | 37701 | Czechia |
| Research Site | Liberec | 525947 | Czechia |
| Research Site | Lovosice | 410 02 | Czechia |
| Research Site | Nový Bor | 473 01 | Czechia |
| Research Site | Ostrava-Hrabuvka | 700 30 | Czechia |
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| Research Site | Prague | 140 00 | Czechia |
| Research Site | Prague | 140 59 | Czechia |
| Research Site | Prague | 15000 | Czechia |
| Research Site | Prague | 16900 | Czechia |
| Research Site | Prague | 190 00 | Czechia |
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| Research Site | Bamberg | 96049 | Germany |
| Research Site | Berlin | 10119 | Germany |
| Research Site | Berlin | 10629 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 12157 | Germany |
| Research Site | Berlin | 13156 | Germany |
| Research Site | Berlin | 14059 | Germany |
| Research Site | Cologne | 51069 | Germany |
| Research Site | Darmstadt | 64283 | Germany |
| Research Site | Essen | 45355 | Germany |
| Research Site | Frankfurt | 60596 | Germany |
| Research Site | Hamburg | 20253 | Germany |
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| Research Site | Leipzig | 04109 | Germany |
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| Research Site | Lübeck | 23552 | Germany |
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| Research Site | Saint Petersburg | 194291 | Russia |
| Research Site | Saint Petersburg | 194354 | Russia |
| Research Site | Saint Petersburg | 196084 | Russia |
| Research Site | Saint Petersburg | 196143 | Russia |
| Research Site | Saint Petersburg | 196247 | Russia |
| Research Site | Saint Petersburg | 196601 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 197089 | Russia |
| Research Site | Saint Petersburg | 197342 | Russia |
| Research Site | Saint Petersburg | 198260 | Russia |
| Research Site | Saratov | 410012 | Russia |
| Research Site | Smolensk | 214006 | Russia |
| Research Site | Smolensk | 214019 | Russia |
| Research Site | Ulyanovsk | 432009 | Russia |
| Research Site | Vladimir | 600023 | Russia |
| Research Site | Voronezh | 394066 | Russia |
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| Research Site | Anyang-si | 14068 | South Korea |
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| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02559 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03181 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
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| Research Site | Seoul | 06591 | South Korea |
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| Related Info | View source |
| Related Info | View source |
| Related Info | View source |
| FG002 | FF MDI 9.6 μg | Formoterol Fumarate Metered Dose Inhalation 9.6 μg |
| FG003 | BD MDI 320 μg | Budesonide Metered Dose Inhalation 320 μg |
| FG004 | Symbicort TBH 400/12 μg | Symbicort Turbuhaler 400/12 μg |
|
| COMPLETED | Completed Treatment |
|
| NOT COMPLETED |
|
|
The Modified Intent-To-Treat (mITT) Population is a subset of the ITT Population, and is defined as all subjects with post-randomization data obtained prior to discontinuation from treatment. The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment and received any amount of the study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BFF MDI 320/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg |
| BG001 | BFF MDI 160/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg |
| BG002 | FF MDI 9.6 μg | Formoterol Fumarate Metered Dose Inhalation 9.6 μg |
| BG003 | BD MDI 320 μg | Budesonide Metered Dose Inhalation 320 μg |
| BG004 | Symbicort TBH 400/12 μg | Symbicort Turbuhaler 400/12 μg |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | mITT | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | mITT | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | mITT | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | mITT | Count of Participants | Participants |
|
| 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 | Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) | Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI) | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | at Week 24 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI) | Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | at Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). | Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI). | mITT | Posted | Number | 95% Confidence Interval | Percentage of Participants | over 24 Weeks (timepoints of 4, 12 & 20 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24 | The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. | mITT | Posted | Number | Percentage of Subjects | at Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI) | Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI) | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | at Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI) | Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI) | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | at Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI) | Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI) | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Puffs per day | over 24 Weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 5 Minutes |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 15 Minutes |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 30 Minutes |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 1 Hour |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 2 Hours |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination | Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 - 4 Hours |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Substudy: 12-hour PFT Endpoint FEV1 AUC0-12 | Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period. | mITT | Posted | Least Squares Mean | 95% Confidence Interval | Liter | at Week 12 |
|
Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BFF MDI 320/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg | 3 | 655 | 42 | 655 | 240 | 655 |
| EG001 | BFF MDI 160/9.6 μg | Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg | 2 | 637 | 45 | 637 | 201 | 637 |
| EG002 | FF MDI 9.6 μg | Formoterol Fumarate Metered Dose Inhalation 9.6 μg | 2 | 644 | 72 | 644 | 219 | 644 |
| EG003 | BD MDI 320 μg | Budesonide Metered Dose Inhalation 320 μg | 0 | 206 | 15 | 206 | 75 | 206 |
| EG004 | Symbicort TBH 400/12 μg | Symbicort Turbuhaler 400/12 μg | 2 | 219 | 20 | 219 | 57 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal hernia gangrenous | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRa | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRa | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dural tear | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer male | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes with hyperosmolarity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Device battery issue | Product Issues | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | medDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul M. Dorinsky, MD | Pearl Therapeutics, a Member of the AstraZeneca Group | 650-305-2600 | paul.dorinsky1@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2017 | Jun 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
|
|
|
|
Symbicort Turbuhaler 400/12 ug |
|
|
Symbicort Turbuhaler 400/12 ug
|
|
| OG003 | BD MDI 320 μg | Budesonide Metered Dose Inhalation 320 μg |
| OG004 | Symbicort TBH 400/12 μg | Symbicort Turbuhaler 400/12 μg |
|
|
|
|
|
|
|
|
| OG004 |
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| OG004 |
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| OG004 |
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| OG004 |
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| OG004 |
| Symbicort TBH 400/12 μg |
Symbicort Turbuhaler 400/12 μg |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|