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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505787-11 | Registry Identifier | CTIS | |
| 2020-001520-34 | 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 (KALOS/LOGOS): Rate of Severe Asthma Exacerbations | Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 forced expiratory volume in 1 second (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).
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 half-lives 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 Chronic Obstructive Pulmonary Disease (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 Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saraland | Alabama | 36571 | 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 D5982C00007\_SAP\_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 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, and Symbicort pMDI 320/9 μg. 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 2274 subjects were randomized at 378 study centers in 20 countries from 15 December 2020. The last subject completed their last study visit on 21 March 2025. Of the 2274 randomized subjects, all populations excluded 125 subjects due to GCP violations and 5 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 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 the 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 the 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): Time to First Severe Asthma Exacerbation | Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations | Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). 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 or 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 (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Research Site | Phoenix | Arizona | 85027 | United States |
| Research Site | Sun City West | Arizona | 85375 | United States |
| Research Site | Tucson | Arizona | 85715 | United States |
| Research Site | Tucson | Arizona | 85745 | United States |
| Research Site | Little Rock | Arkansas | 72209 | United States |
| Research Site | Covina | California | 91723 | United States |
| Research Site | Encinitas | California | 92024 | United States |
| Research Site | Fresno | California | 93701 | United States |
| Research Site | Laguna Hills | California | 92653 | United States |
| Research Site | Long Beach | California | 90806 | United States |
| Research Site | Los Angeles | California | 90017 | United States |
| Research Site | Los Angeles | California | 90027 | United States |
| Research Site | Mission Hills | California | 91345 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Northridge | California | 91324 | United States |
| Research Site | San Diego | California | 92119 | United States |
| Research Site | Stockton | California | 95207 | United States |
| Research Site | Thousand Oaks | California | 91360 | United States |
| Research Site | Upland | California | 91786 | United States |
| Research Site | Westminster | California | 92683 | United States |
| Research Site | Colorado Springs | Colorado | 80923 | United States |
| Research Site | Lakewood | Colorado | 80228 | United States |
| Research Site | Brandon | Florida | 33511 | United States |
| Research Site | Miami | Florida | 33175 | United States |
| Research Site | Tampa | Florida | 33607 | United States |
| Research Site | Adairsville | Georgia | 30103 | United States |
| Research Site | Atlanta | Georgia | 30344 | United States |
| Research Site | Columbus | Georgia | 31904 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Rincon | Georgia | 31326 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Tyrone | Georgia | 30290 | United States |
| Research Site | Chicago | Illinois | 60657 | United States |
| Research Site | River Forest | Illinois | 60305 | United States |
| Research Site | Brownsburg | Indiana | 46112 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Louisville | Kentucky | 40217 | United States |
| Research Site | Crowley | Louisiana | 70526 | United States |
| Research Site | Lafayette | Louisiana | 70508 | United States |
| Research Site | Lake Charles | Louisiana | 70601 | United States |
| Research Site | Bangor | Maine | 04401 | United States |
| Research Site | Potomac | Maryland | 20854 | United States |
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| Research Site | Boston | Massachusetts | 02115 | United States |
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| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Missoula | Montana | 59808 | United States |
| Research Site | Bellevue | Nebraska | 68123 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | Las Vegas | Nevada | 89106 | United States |
| Research Site | Toms River | New Jersey | 08755 | United States |
| Research Site | Albuquerque | New Mexico | 87108 | United States |
| Research Site | New Hyde Park | New York | 11042 | United States |
| Research Site | New Windsor | New York | 12553 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | The Bronx | New York | 10455 | United States |
| Research Site | Charlotte | North Carolina | 28277 | United States |
| Research Site | Denver | North Carolina | 28037 | United States |
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| Research Site | Raleigh | North Carolina | 27607 | United States |
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| Research Site | DuBois | Pennsylvania | 15801 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15236 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Site | Scottdale | Pennsylvania | 15683 | United States |
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| Research Site | East Providence | Rhode Island | 02914 | United States |
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| Research Site | Harlingen | Texas | 78550 | United States |
| Research Site | Houston | Texas | 77021 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Kerrville | Texas | 78028 | United States |
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| Research Site | Nederland | Texas | 77627 | United States |
| Research Site | Pearland | Texas | 77584 | United States |
| Research Site | Red Oak | Texas | 75154 | United States |
| Research Site | San Antonio | Texas | 78215 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Spring | Texas | 77386 | United States |
| Research Site | Tomball | Texas | 77375 | United States |
| Research Site | Ogden | Utah | 84404 | United States |
| Research Site | West Valley City | Utah | 84120 | United States |
| Research Site | Colchester | Vermont | 05446 | United States |
| Research Site | Manassas | Virginia | 20110 | United States |
| Research Site | Kingwood | West Virginia | 26537 | United States |
| Research Site | Morgantown | West Virginia | 26505 | United States |
| Research Site | Cudahy | Wisconsin | 53110 | United States |
| Research Site | Buenos Aires | C1121ABE | Argentina |
| Research Site | CABA | 1056 | Argentina |
| Research Site | CABA | C1425BEN | Argentina |
| Research Site | Ciudad de Buenos Aires | 1425 | Argentina |
| Research Site | Ciudad de Buenos Aires | C1280AEB | Argentina |
| Research Site | Ciudad de Buenos Aires | C1414AIF | Argentina |
| Research Site | Córdoba | X5003DCE | Argentina |
| Research Site | Florida | B1602DQD | Argentina |
| Research Site | Mar del Plata | 7600 | Argentina |
| Research Site | Mendoza | M5500CCG | Argentina |
| Research Site | Ranelagh | 1886 | Argentina |
| Research Site | Rosario | 2000 | Argentina |
| Research Site | Rosario | S2000DEJ | Argentina |
| Research Site | San Fernando | B1646EBJ | Argentina |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Namur | 5101 | Belgium |
| Research Site | Dupnitsa | 2600 | Bulgaria |
| Research Site | Dupnitsa | 2602 | Bulgaria |
| Research Site | Haskovo | 6305 | Bulgaria |
| Research Site | Kozloduy | 3320 | Bulgaria |
| Research Site | Lovech | 5500 | Bulgaria |
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| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Stara Zagora | 6000 | Bulgaria |
| Research Site | Stara Zagora | 6003 | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Veliko Tarnovo | 5000 | Bulgaria |
| Research Site | Vidin | 3700 | Bulgaria |
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| Research Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Research Site | Sherwood Park | Alberta | T8H 2M7 | Canada |
| Research Site | Kelowna | British Columbia | V1Y 4N7 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Research Site | Winnipeg | Manitoba | R2V 4W3 | Canada |
| Research Site | Winnipeg | Manitoba | R3L 1Z5 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Hamilton | Ontario | L8S 1G5 | Canada |
| Research Site | London | Ontario | N6A 1V2 | Canada |
| Research Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Research Site | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Research Site | Toronto | Ontario | M5G 1E2 | Canada |
| Research Site | Toronto | Ontario | M9V 4B4 | Canada |
| Research Site | Québec | Quebec | G1G 3Y8 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Québec | Quebec | G2J 0C4 | Canada |
| Research Site | Chile | 7770484 | Chile |
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| Research Site | Balassagyarmat | 2660 | Hungary |
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| Research Site | Encs | 3860 | Hungary |
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| Research Site | Kyoto | 612-8555 | Japan |
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| Research Site | Osaka | 530-0001 | Japan |
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| Research Site | Setagaya-ku | 157-0072 | Japan |
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| Research Site | Toshima-ku | 171-0014 | Japan |
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| Research Site | Rzeszów | 35-205 | Poland |
| Research Site | Sosnowiec | 41-200 | Poland |
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| Research Site | Strzelce Opolskie | 47-100 | Poland |
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| Research Site | Seoul | 03312 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Uijeongbu-si | 11765 | South Korea |
| Research Site | Ulsan | 44033 | South Korea |
| Research Site | Barcelona | 08017 | Spain |
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| Research Site | Coslada | 28822 | Spain |
| Research Site | L'Hospitalet de Llobregat | 08907 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28031 | Spain |
| Research Site | Marbella (Málaga) | 29603 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Pozuelo de Alarcón | 28223 | Spain |
| Research Site | Santander | 39008 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Zaragoza | 50015 | Spain |
| Research Site | Changhua | 50006 | Taiwan |
| Research Site | Kaohsiung City | 80756 | Taiwan |
| Research Site | Kaohsiung City | 833 | Taiwan |
| Research Site | New Taipei City | 23561 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 10449 | Taiwan |
| Research Site | Taipei | 110 | Taiwan |
| Research Site | Taoyuan | Taiwan |
| Research Site | Bang Kra So | 11000 | Thailand |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Bangkok | 10400 | Thailand |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Chanthaburi | 22000 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Khon Kaen | 40002 | Thailand |
| Research Site | Muang | 55000 | Thailand |
| Research Site | Mueang | 20000 | Thailand |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hà Nội | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Ho Chi Minh City | 70000 | Vietnam |
| Research Site | Hochiminh | 700000 | Vietnam |
| 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. |
| D5982C00007\_CSP\_Redacted | View source |
| D5982C00007\_CSR synopsis\_Redacted | View source |
| FG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| FG003 | Symbicort® pMDI 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® pMDI 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 (%) | Reversibility (%) was calculated as (Post-Albuterol FEV1 - Pre-Albuterol FEV1)/Pre-Albuterol FEV1 x 100 | Based on Efficacy Set | Mean | Standard Deviation | Percentage |
| ||||||||
| Baseline Pre-bronchodilator Percent Predicted FEV1 (%) | Mean | Standard Deviation | Percentage |
| ||||||||||
| Baseline Severe Asthma Exacerbation History Within the Prior Year | Number | Participants |
| |||||||||||
| Prior Inhaled Corticosteroid (ICS) Dose | Classification of the prior inhaled corticosteroid (ICS) total daily dose (defined as a stable dose for at least 4 weeks prior to Visit 1). | Number | 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 (KALOS/LOGOS): Rate of Severe Asthma Exacerbations | Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 D5982C00008 (NCT04609904). | 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 forced expiratory volume in 1 second (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 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 the 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 the 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 D5982C00008 (NCT04609904). | Posted | Number | Exacerbations/Subject Years | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 D5982C00008 (NCT04609904). | Posted | Number | Exacerbations/Subject Years | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): Time to First Severe Asthma Exacerbation | Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). 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 D5982C00008 (NCT04609904). | Posted | Number | Percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations | Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 D5982C00008 (NCT04609904). | Posted | Number | Exacerbations/Subject Years | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). 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 or 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 D5982C00008 (NCT04609904). | Posted | Number | Percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 D5982C00008 (NCT04609904). | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 D5982C00008 (NCT04609904). | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24 | Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 D5982C00008 (NCT04609904). | 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 MD I320/14.4/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI | 1 | 342 | 18 | 342 | 81 | 342 |
| EG001 | BGF MDI 320/28.8/9.6 μg BID | Budesonide, glycopyrronium, and formoterol fumarate MDI | 1 | 594 | 32 | 594 | 109 | 594 |
| EG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI | 1 | 606 | 34 | 606 | 123 | 606 |
| EG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI | 2 | 602 | 32 | 602 | 119 | 602 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dengue haemorrhagic fever | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Eye abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infective exacerbation of asthma | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Mucinous breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cervicogenic vertigo | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mycoardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paranasal sinus inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 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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| Belgium |
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| Bulgaria |
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| Canada |
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| Chile |
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| Hungary |
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| India |
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| Italy |
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| Japan |
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| New Zealand |
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| Peru |
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| Philippines |
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| Poland |
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| Korea, Republic Of |
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| Romania |
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| Spain |
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| Taiwan, China |
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| Thailand |
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| United States |
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| Viet Nam |
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| 1 exacerbation |
|
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| ≥2 exacerbations |
|
|
|
| Medium |
|
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| High |
|
|
| Missing |
|
|
| The repeated measures ANCOVA 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 | 0.068 | Standard Error of the Mean | 0.020 | 2-Sided | 95 | 0.029 | 0.106 | An increase in estimate for comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates used in the analysis model were included in the analysis. | Superiority |
Budesonide, glycopyrronium, and formoterol fumarate MDI
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| Symbicort® pMDI 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide/formoterol fumarate pMDI |
|
|
|
| Symbicort® pMDI 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide/formoterol fumarate pMDI |
|
|
|
| OG003 |
| Symbicort® pMDI 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
| Symbicort® pMDI 320/9 μg BID |
Budesonide/formoterol fumarate pMDI |
|
|
|
| BGF MDI 320/28.8/9.6 μg BID |
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| OG001 |
| BGF MDI 320/28.8/9.6 μg BID |
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| BFF MDI 320/9.6 μg BID |
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| BGF MDI 320/28.8/9.6 μg BID |
Budesonide, glycopyrronium, and formoterol fumarate MDI |
| OG002 | BFF MDI 320/9.6 μg BID | Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
| OG002 |
| BFF MDI 320/9.6 μg BID |
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|
Budesonide and formoterol fumarate MDI |
| OG003 | Symbicort® pMDI 320/9 μg BID | Budesonide/formoterol fumarate pMDI |
|
|
|