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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505786-88 | Registry Identifier | CTIS | |
| 2020-001521-31 | EudraCT Number |
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This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg | Experimental | BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
|
| BGF MDI 320/14.4/9.6 μg | Experimental | BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
|
| Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg | Active Comparator | BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) |
|
| Symbicort® | Active Comparator | Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGF MDI 320/28.8/9.6 μg | Drug | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 AUC0-3 (L) at Week 24 | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations | Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24 | Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. |
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Inclusion Criteria:
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
Demonstrate acceptable MDI/pMDI administration technique.
Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
Exclusion Criteria:
1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.
3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
4. Current evidence of COPD.
5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.
5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.
5c. Depot corticosteroid use for any reason within 3 months of V1.
6. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.
7. Use of oral beta2-agonist within 3 months of V1.
8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.
10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
11. Hospitalization for asthma within 2 months of Visit 1.
12. Known history of drug or alcohol abuse within 12 months of Visit 1.
13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.
15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.
16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.
17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Please refer to the study protocol for the complete inclusion and exclusion criteria list
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wise, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41692019 | Derived | Papi A, Wise RA, Jackson DJ, Lugogo N, Chen R, Trasieva T, Obasi C, Movitz C, Helman J, Salter P, Springer K, Bondoc M, Shah M, Knappenberger K, Bowen K, Pandya H, Megally A, Patel M; KALOS and LOGOS study investigators. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026 Apr;14(4):350-362. doi: 10.1016/S2213-2600(25)00457-6. Epub 2026 Feb 12. | |
| 36472162 |
| Label | URL |
|---|---|
| D5982C00008\_CSP\_Redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Adult and adolescent subjects with inadequately controlled moderate to severe asthma were randomized to 1 of 4 treatment groups: BGF MDI 320/14.4/9.6 μg, BGF MDI 320/28.8/9.6 μg, BFF MDI, and Symbicort pMDI. Subjects who were eligible for the study discontinued their medium or high dose ICS/LABA at Visit 1 and initiated run-in BFF MDI until randomization.
A total of 2187 subjects were randomized at 324 study centers in 15 countries from 01 March 2021. The last subject completed their last study visit on 20 March 2025. Of the 2187 randomized subjects, all populations excluded 16 subjects due to GCP violations and 4 subjects due to not receiving study therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | BGF MDI 320/14.4/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI |
| FG001 | BGF MDI 320/28.8/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI |
| 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 | Nov 19, 2024 | Feb 19, 2026 |
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|
| BGF MDI 320/14.4/9.6 μg | Drug | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
|
|
| BFF MDI 320/9.6 μg | Drug | Budesonide and formoterol fumarate metered dose inhaler |
|
|
| BFF pMDI 320/9 μg | Drug | Budesonide/formoterol fumarate pressurized metered dose inhaler |
|
|
| Week 24 |
| Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1 | Onset of action on Day 1: Absolute change in FEV1 (L) at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Day 1 |
| Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24 | Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]) +12 (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24 | Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline | Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 Weeks |
| Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1 | Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 Weeks |
| Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation | Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 weeks |
| Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations | Rate of moderate/severe exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate exacerbation was a worsening of symptoms that resulted in additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 Weeks |
| Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation | Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate/severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Up to 52 weeks |
| Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24 | Percentage of responders in AQLQ(s) +12 (≥0.5 increase equals response) at Week 24 was assessed in a pre- specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | Week 24 |
| Tempe |
| Arizona |
| 85283 |
| United States |
| Research Site | Tucson | Arizona | 85741 | United States |
| Research Site | Hot Springs | Arkansas | 71913 | United States |
| Research Site | Bakersfield | California | 93301 | United States |
| Research Site | Carlsbad | California | 92008 | United States |
| Research Site | Huntington Beach | California | 92647 | United States |
| Research Site | Lancaster | California | 93534 | United States |
| Research Site | Long Beach | California | 90815 | United States |
| Research Site | Mission Viejo | California | 92691 | United States |
| Research Site | North Hollywood | California | 91606 | United States |
| Research Site | Northridge | California | 91324 | United States |
| Research Site | Rancho Cucamonga | California | 91730 | United States |
| Research Site | Sacramento | California | 95823 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | San Jose | California | 95117 | United States |
| Research Site | Ventura | California | 93003 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Colorado Springs | Colorado | 80910 | United States |
| Research Site | Wheat Ridge | Colorado | 80033 | United States |
| Research Site | Newark | Delaware | 19713 | United States |
| Research Site | Boca Raton | Florida | 33487 | United States |
| Research Site | Clearwater | Florida | 33756 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | Cutler Bay | Florida | 33189 | United States |
| Research Site | DeBary | Florida | 32713 | United States |
| Research Site | Hialeah | Florida | 33016 | United States |
| Research Site | Lakeland | Florida | 33813 | United States |
| Research Site | Miami | Florida | 33135 | United States |
| Research Site | Tampa | Florida | 33615 | United States |
| Research Site | Acworth | Georgia | 30101 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Atlanta | Georgia | 30350 | United States |
| Research Site | Snellville | Georgia | 30078 | United States |
| Research Site | Boise | Idaho | 83706 | United States |
| Research Site | Chicago | Illinois | 60621 | United States |
| Research Site | Normal | Illinois | 61761 | United States |
| Research Site | Peoria | Illinois | 61636 | United States |
| Research Site | Evansville | Indiana | 47715 | United States |
| Research Site | Marrero | Louisiana | 70072 | United States |
| Research Site | Zachary | Louisiana | 70791 | United States |
| Research Site | Baltimore | Maryland | 21224 | United States |
| Research Site | White Marsh | Maryland | 21162 | United States |
| Research Site | Fall River | Massachusetts | 02723 | United States |
| Research Site | Farmington Hills | Michigan | 48336 | United States |
| Research Site | Rochester | Michigan | 48307 | United States |
| Research Site | Troy | Michigan | 48085 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Warrensburg | Missouri | 64093 | United States |
| Research Site | North Las Vegas | Nevada | 89030 | United States |
| Research Site | Portsmouth | New Hampshire | 03801 | United States |
| Research Site | Ocean City | New Jersey | 07712 | United States |
| Research Site | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Brooklyn | New York | 11236 | United States |
| Research Site | The Bronx | New York | 10459 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | The Bronx | New York | 10468 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | Monroe | North Carolina | 28112 | United States |
| Research Site | Columbus | Ohio | 43215 | United States |
| Research Site | Portland | Oregon | 97202 | United States |
| Research Site | Jenkintown | Pennsylvania | 19046 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Knoxville | Tennessee | 37909 | United States |
| Research Site | Amarillo | Texas | 79106 | United States |
| Research Site | Cedar Park | Texas | 78613 | United States |
| Research Site | Dallas | Texas | 75254 | United States |
| Research Site | Denison | Texas | 75020 | United States |
| Research Site | Forney | Texas | 75126 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | Lewisville | Texas | 75067 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | North Richland Hills | Texas | 76180 | United States |
| Research Site | Pearland | Texas | 77584 | United States |
| Research Site | Plano | Texas | 75093 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Sugar Land | Texas | 77478 | United States |
| Research Site | Victoria | Texas | 77901 | United States |
| Research Site | Roy | Utah | 84067 | United States |
| Research Site | Abingdon | Virginia | 24210 | United States |
| Research Site | Burke | Virginia | 22015 | United States |
| Research Site | Williamsburg | Virginia | 23188 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Milwaukee | Wisconsin | 53228 | United States |
| Research Site | Botucatu | 18618-970 | Brazil |
| Research Site | Porto Alegre | 9002-060 | Brazil |
| Research Site | Porto Alegre | 90430-001 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Santo André | 09080-110 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Sorocaba | 18040-425 | Brazil |
| Research Site | Baotou | 014010 | China |
| Research Site | Beijing | 100020 | China |
| Research Site | Changsha | 410005 | China |
| Research Site | Changsha | 410008 | China |
| Research Site | Changsha | 430033 | China |
| Research Site | Changzhi | 46000 | China |
| Research Site | Chengdu | 610072 | China |
| Research Site | Chengdu | 611130 | China |
| Research Site | Chizhou | 247099 | China |
| Research Site | Chongqing | 400010 | China |
| Research Site | Chongqing | 400038 | China |
| Research Site | Dongguan | 523413 | China |
| Research Site | Dongyang | 322100 | China |
| Research Site | Fuzhou | 350025 | China |
| Research Site | Guangzhou | 510062 | China |
| Research Site | Guangzhou | 510100 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510180 | China |
| Research Site | Guangzhou | 510280 | China |
| Research Site | Guangzhou | 510630 | China |
| Research Site | Haikou | 570208 | China |
| Research Site | Haikou | 570311 | China |
| Research Site | Hangzhou | 310005 | China |
| Research Site | Hangzhou | 310009 | China |
| Research Site | Hefei | 230000 | China |
| Research Site | Hefei | 230011 | China |
| Research Site | Hefei | 230061 | China |
| Research Site | Huai'an | 223300 | China |
| Research Site | Huizhou | 516001 | China |
| Research Site | Jinan | 250014 | China |
| Research Site | Jinhua | 321000 | China |
| Research Site | Kunming | 650032 | China |
| Research Site | Kunming | 650051 | China |
| Research Site | Lanzhou | 730000 | China |
| Research Site | Liuzhou | 545006 | China |
| Research Site | Luoyang | 471003 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanchong | 637000 | China |
| Research Site | Nanjing | 210006 | China |
| Research Site | Nanjing | 210008 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Qingdao | 266000 | China |
| Research Site | Qingdao | 266042 | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200065 | China |
| Research Site | Shanghai | 200080 | China |
| Research Site | Shanghai | 200092 | China |
| Research Site | Shanghai | 200240 | China |
| Research Site | Shanghai | 201199 | China |
| Research Site | Shaoxing | 312000 | China |
| Research Site | Shengyang | 110004 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Shenyang | 110015 | China |
| Research Site | Shenyang | 110075 | China |
| Research Site | Shenzhen | 518020 | China |
| Research Site | Shenzhen | 518036 | China |
| Research Site | Shenzhen | 518039 | China |
| Research Site | Shijiazhuang | 50051 | China |
| Research Site | Taiyuan | 030001 | China |
| Research Site | Taiyuan | 030032 | China |
| Research Site | Taizhou | 318020 | China |
| Research Site | Ürümqi | 830054 | China |
| Research Site | Weifang | 261000 | China |
| Research Site | Wuhan | 430010 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Wuhu | 241000 | China |
| Research Site | Xi'an | 710004 | China |
| Research Site | Xi'an | 710077 | China |
| Research Site | Xinxiang | 453002 | China |
| Research Site | Xuzhou | 221000 | China |
| Research Site | Xuzhou | 221009 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Yantai | 264000 | China |
| Research Site | Yinchuan | 750001 | China |
| Research Site | Yinchuan | 750004 | China |
| Research Site | Yueyang | 414000 | China |
| Research Site | Zhangzhou | 363099 | China |
| Research Site | Zhanjiang | 524001 | China |
| Research Site | Zhengzhou | 450000 | China |
| Research Site | Zhuji | 311899 | China |
| Research Site | Barranquilla | 080020 | Colombia |
| Research Site | Bogotá | 110221 | Colombia |
| Research Site | Cartagena | 130013 | Colombia |
| Research Site | Medellín | 050621 | Colombia |
| Research Site | Rionegro | 054047 | Colombia |
| Research Site | Brandýs nad Labem | 250 01 | Czechia |
| Research Site | Jindřichův Hradec | 377 01 | Czechia |
| Research Site | Lovosice | 410 02 | Czechia |
| Research Site | Mladá Boleslav | 293 01 | Czechia |
| Research Site | Nový Bor | 473 01 | Czechia |
| Research Site | Prague | 148 00 | Czechia |
| Research Site | Prague | 190 00 | Czechia |
| Research Site | Rokycany | 337 22 | Czechia |
| Research Site | Strakonice | 38601 | Czechia |
| Research Site | Teplice | 415 01 | Czechia |
| Research Site | Varnsdorf | 407 47 | Czechia |
| Research Site | Bamberg | 96049 | Germany |
| Research Site | Berlin | 10119 | Germany |
| Research Site | Berlin | 10367 | Germany |
| Research Site | Berlin | 10717 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 12159 | Germany |
| Research Site | Berlin | 12203 | Germany |
| Research Site | Berlin | 13187 | Germany |
| Research Site | Darmstadt | 64283 | Germany |
| Research Site | Frankfurt | 60596 | Germany |
| Research Site | Frankfurt am Main | 60389 | Germany |
| Research Site | Frankfurt am Main | 60596 | Germany |
| Research Site | Fürstenwalde | 15517 | Germany |
| Research Site | Geesthacht | 21502 | Germany |
| Research Site | Hanover | 30449 | Germany |
| Research Site | Hanover | D-30173 | Germany |
| Research Site | Heidelberg | 69115 | Germany |
| Research Site | Koblenz | 56068 | Germany |
| Research Site | Landsberg | 86899 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Leipzig | 04207 | Germany |
| Research Site | Leipzig | 04299 | Germany |
| Research Site | Mainz | 55128 | Germany |
| Research Site | München-Pasing | 81241 | Germany |
| Research Site | Witten | 58452 | Germany |
| Research Site | Alexandroupoli | 68100 | Greece |
| Research Site | Athens | 11521 | Greece |
| Research Site | Athens | 11527 | Greece |
| Research Site | Athens | 12462 | Greece |
| Research Site | Athens | 17562 | Greece |
| Research Site | Corfu | 49100 | Greece |
| Research Site | Exohi Thessaloniki | 57010 | Greece |
| Research Site | Ioannina | 45500 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Thessaloniki | 57010 | Greece |
| Research Site | Ashkelon | 7830604 | Israel |
| Research Site | Beersheba | 84101 | Israel |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Haifa | 34362 | Israel |
| Research Site | Holon | 5837738 | Israel |
| Research Site | Jerusalem | 9103102 | Israel |
| Research Site | Jerusalem | 9112001 | Israel |
| Research Site | Kfar Saba | 4428164 | Israel |
| Research Site | Petah Tikva | 4920235 | Israel |
| Research Site | Rehovot | 76100 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Cuernavaca | 62290 | Mexico |
| Research Site | Durango | 43080 | Mexico |
| Research Site | Guadalajara | 44200 | Mexico |
| Research Site | Mazatlán | 82000 | Mexico |
| Research Site | Mérida | 97070 | Mexico |
| Research Site | Monterrey | 64620 | Mexico |
| Research Site | Monterrey | 64710 | Mexico |
| Research Site | Monterrey | 64718 | Mexico |
| Research Site | Veracruz | 91910 | Mexico |
| Research Site | Villahermosa | 86035 | Mexico |
| Research Site | Zapopan | 45138 | Mexico |
| Research Site | Amadora | 2720-276 | Portugal |
| Research Site | Braga | 4710 | Portugal |
| Research Site | Coimbra | 3040-316 | Portugal |
| Research Site | Figueira da Foz Municipality | 3094-001 | Portugal |
| Research Site | Guimarães | 4835-044 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Lisbon | 1998-018 | Portugal |
| Research Site | Matosinhos Municipality | 4454-509 | Portugal |
| Research Site | Ponce | 00717 | Puerto Rico |
| Research Site | Ponce | 00780 | Puerto Rico |
| Research Site | Chelyabinsk | 454106 | Russia |
| Research Site | Izhevsk | 426035 | Russia |
| Research Site | Kazan' | 420008 | Russia |
| Research Site | Kemerovo | 650002 | Russia |
| Research Site | Moscow | 115522 | Russia |
| Research Site | Moscow | 125284 | Russia |
| Research Site | Omsk | 644050 | Russia |
| Research Site | Penza | 440067 | Russia |
| Research Site | Perm | 614000 | Russia |
| Research Site | Saint Petersburg | 194354 | Russia |
| Research Site | Saint Petersburg | 195257 | Russia |
| Research Site | Saratov | 410028 | Russia |
| Research Site | Saratov | 410053 | Russia |
| Research Site | Tomsk | 634050 | Russia |
| Research Site | Ulyanovsk | 432009 | Russia |
| Research Site | Bojnice | 972 01 | Slovakia |
| Research Site | Kežmarok | 060 01 | Slovakia |
| Research Site | Košice | 04022 | Slovakia |
| Research Site | Levice | 934 01 | Slovakia |
| Research Site | Levice | 93401 | Slovakia |
| Research Site | Nové Zámky | 94001 | Slovakia |
| Research Site | Poprad | 058 01 | Slovakia |
| Research Site | Prešov | 081 81 | Slovakia |
| Research Site | Ružomberok | 034 26 | Slovakia |
| Research Site | Šurany | 94201 | Slovakia |
| Research Site | Topoľčany | 95501 | Slovakia |
| Research Site | Žilina | 010 01 | Slovakia |
| Research Site | Bloemfontein | 9301 | South Africa |
| Research Site | Cape Town | 7700 | South Africa |
| Research Site | Cape Town | 7764 | South Africa |
| Research Site | Durban | 4001 | South Africa |
| Research Site | Durban | 4091 | South Africa |
| Research Site | Durban | 4093 | South Africa |
| Research Site | Durban | 4450 | South Africa |
| Research Site | eMkhomazi | 4170 | South Africa |
| Research Site | Johannesburg | 2001 | South Africa |
| Research Site | Lenasia | 1821 | South Africa |
| Research Site | Lenasia Ext8 | 1820 | South Africa |
| Research Site | Panorama | 7500 | South Africa |
| Research Site | Pretoria | 0186 | South Africa |
| Research Site | Tygervalley | 7530 | South Africa |
| Research Site | Adana | 1260 | Turkey (Türkiye) |
| Research Site | Ankara | 06 | Turkey (Türkiye) |
| Research Site | Istanbul | 34098 | Turkey (Türkiye) |
| Research Site | Istanbul | 34844 | Turkey (Türkiye) |
| Research Site | Izmir | 35110 | Turkey (Türkiye) |
| Research Site | Mersin | 33343 | Turkey (Türkiye) |
| Research Site | Pamukkale | 20070 | Turkey (Türkiye) |
| Research Site | Blackpool | FY3 7EN | United Kingdom |
| Research Site | Bradford | BD9 6RJ | United Kingdom |
| Research Site | Corby | NN17 2UR | United Kingdom |
| Research Site | Hull | HU16 5JQ | United Kingdom |
| Research Site | Leicester | LE5 4LJ | United Kingdom |
| Research Site | Rhyl | LL18 1DA | United Kingdom |
| Derived |
| Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. |
| D5982C00008\_D5982C00007\_SAP\_Redacted | View source |
| D5982C00008\_CSR Synopsis\_Redacted | View source |
| FG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| FG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
| COMPLETED | Completed the Study |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BGF MDI 320/14.4/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI |
| BG001 | BGF MDI 320/28.8/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI |
| BG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| BG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
| BG004 | 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, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | Participants |
| |||||||||||
| Baseline Reversibility (%) | Baseline reversibility (%) calculated as (Post-Albuterol FEV1 - Pre-Albuterol FEV1)/ Pre-Albuterol FEV1 x 100 | Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies. | Mean | Standard Deviation | Percentage |
| ||||||||
| Baseline Pre-bronchodilator Percent Predicted FEV1 (%) | Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies. | Mean | Standard Deviation | Percentage |
| |||||||||
| Baseline Severe Asthma Exacerbation History Within the Prior Year | Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies. | Count of Participants | Participants |
| ||||||||||
| Prior Inhaled Corticosteroid (ICS) Dose | Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies. | 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 FEV1 AUC0-3 (L) at Week 24 | Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Least Squares Mean | Standard Error | Liters | Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations | Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Number | Exacerbations/Subject Years | Up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24 | Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Least Squares Mean | Standard Error | Liters | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1 | Onset of action on Day 1: Absolute change in FEV1 (L) at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Mean | Standard Deviation | Liters | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24 | Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]) +12 (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24 | Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline | Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Number | Exacerbations/Subject Years | Up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1 | Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Number | Exacerbations/Subject Years | Up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation | Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 [NCT04609878]. | Posted | Number | Percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations | Rate of moderate/severe exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate exacerbation was a worsening of symptoms that resulted in additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Number | Exacerbations/Subject Years | Up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation | Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate/severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Number | Percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24 | Percentage of responders in AQLQ(s) +12 (≥0.5 increase equals response) at Week 24 was assessed in a pre- specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented. | The Efficacy Set included all subjects who were randomized to study treatment and received any amount of study treatment. Subjects were analyzed according to the study treatment assigned at randomization, regardless of the study treatment received. As per protocol, data was summarized for the Efficacy Set using pooled data from subjects in this study and D5982C00007 (NCT04609878). | Posted | Count of Participants | Participants | Week 24 |
|
Up to 52 Weeks with a 2-week safety follow-up period; adverse events were collected from first intake of study intervention after Visit 1, during screening and throughout the Treatment Period and including the follow-up period. "All-Cause Mortality" events are presented for the on-study period and SAEs are presented for the on-treatment period.
The Safety Set was defined as all subjects who were randomized to study treatment and received any amount of randomized study treatment. Subjects were analyzed according to the actual study treatment received rather than the study treatment randomized. The actual study treatment was defined as the study treatment that the subject received the most, based on number of puffs.
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 | BGF MDI 320/14.4/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI | 0 | 384 | 31 | 384 | 122 | 384 |
| EG001 | BGF MDI 320/28.8/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI | 3 | 585 | 41 | 585 | 157 | 585 |
| EG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI | 3 | 604 | 49 | 604 | 169 | 604 |
| EG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI | 1 | 594 | 36 | 594 | 162 | 594 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial bridging | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Eosinophilic granulomatosis with polyangitis | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Open angle glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dilated cardiomyopathy | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis noninfective | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia pnuemococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperammonaemic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
The study was conducted during the SARS-CoV-2 pandemic, resulting in recruitment difficulties. As such, protocol amendments were instituted to facilitate recruitment, including removal of history of exacerbation criterion and terminating recruitment to the BGF MDI 320/14.4/9.6 μg treatment group.
The confidentiality agreement is a part of the clinical study agreement and does not contain any information on any type of embargo; it includes a statement that the PI should not share/discuss the study results for up to 10 years after the agreement expires.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Head | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2025 | Feb 19, 2026 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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| China |
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| Colombia |
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| Czech Republic |
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| Germany |
|
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| United Kingdom |
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| Greece |
|
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| Israel |
|
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| Mexico |
|
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| Portugal |
|
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| Russia |
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| Slovakia |
|
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| South Africa |
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| Turkey |
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| United States |
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| The analysis was performed using a repeated measures ANCOVA. The model included treatment, visit, prior ICS dose (medium vs. high), and treatment-by-visit interaction as categorical covariates and baseline trough FEV1 and percent reversibility as continuous covariates. | ANCOVA | <0.001 | LS Mean Difference | 0.134 | Standard Error of the Mean | 0.021 | 2-Sided | 95 | 0.093 | 0.175 | An increase in estimate for comparison favors study drug. Subject number analyzed based on the Efficacy Set, which excluded 7 subjects randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included in the analysis. | Superiority |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide/formoterol fumarate pMDI |
|
|
|
| Symbicort® 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide/formoterol fumarate pMDI |
|
|
|
| OG003 |
| Symbicort® 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
| Symbicort® 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| BFF MDI 320/9.6 μg BID |
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| OG002 |
| BFF MDI 320/9.6 μg BID |
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|