Trial Outcomes & Findings for Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (NCT NCT04609904)

Last Updated: 2026-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2187 participants

Primary outcome timeframe

Week 24

Results posted on

2026-07-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	BGF MDI 320/14.4/9.6 μg BID Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID Budesonide/formoterol fumarate pMDI
Overall Study STARTED	384	585	604	594
Overall Study COMPLETED	360	535	540	544
Overall Study NOT COMPLETED	24	50	64	50

Reasons for withdrawal

Reasons for withdrawal
Measure	BGF MDI 320/14.4/9.6 μg BID Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID Budesonide/formoterol fumarate pMDI
Overall Study Withdrawal by Subject	13	29	36	32
Overall Study Adverse Event	4	5	2	1
Overall Study Lost to Follow-up	1	2	6	7
Overall Study Reasons not specified	3	4	6	1
Overall Study Lack of Efficacy	1	2	7	1
Overall Study Physician Decision	1	2	2	3
Overall Study Pregnancy	0	2	0	1
Overall Study Death	0	3	3	1
Overall Study Development of study-specific criteria	1	0	0	0
Overall Study Other	0	0	0	1
Overall Study Non-compliance with study drug	0	1	2	2

Baseline Characteristics

Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BFF MDI 320/9.6 μg BID n=604 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=594 Participants Budesonide/formoterol fumarate pMDI	Total n=2167 Participants Total of all reporting groups	BGF MDI 320/14.4/9.6 μg BID n=384 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=585 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI
Age, Categorical Age group (years) · <=18 years	17 Participants n=604 Participants	18 Participants n=594 Participants	58 Participants n=2167 Participants	9 Participants n=384 Participants	14 Participants n=585 Participants
Age, Categorical Age group (years) · Between 18 and 65 years	477 Participants n=604 Participants	451 Participants n=594 Participants	1687 Participants n=2167 Participants	312 Participants n=384 Participants	447 Participants n=585 Participants
Age, Categorical Age group (years) · >=65 years	110 Participants n=604 Participants	125 Participants n=594 Participants	422 Participants n=2167 Participants	63 Participants n=384 Participants	124 Participants n=585 Participants
Sex: Female, Male Sex · Female	383 Participants n=604 Participants	370 Participants n=594 Participants	1318 Participants n=2167 Participants	224 Participants n=384 Participants	341 Participants n=585 Participants
Sex: Female, Male Sex · Male	221 Participants n=604 Participants	224 Participants n=594 Participants	849 Participants n=2167 Participants	160 Participants n=384 Participants	244 Participants n=585 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	68 Participants n=604 Participants	60 Participants n=594 Participants	239 Participants n=2167 Participants	40 Participants n=384 Participants	71 Participants n=585 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	536 Participants n=604 Participants	534 Participants n=594 Participants	1928 Participants n=2167 Participants	344 Participants n=384 Participants	514 Participants n=585 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=604 Participants	0 Participants n=594 Participants	0 Participants n=2167 Participants	0 Participants n=384 Participants	0 Participants n=585 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	5 Participants n=604 Participants	9 Participants n=594 Participants	30 Participants n=2167 Participants	9 Participants n=384 Participants	7 Participants n=585 Participants
Race (NIH/OMB) Race · Asian	230 Participants n=604 Participants	231 Participants n=594 Participants	853 Participants n=2167 Participants	170 Participants n=384 Participants	222 Participants n=585 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	1 Participants n=604 Participants	0 Participants n=594 Participants	1 Participants n=2167 Participants	0 Participants n=384 Participants	0 Participants n=585 Participants
Race (NIH/OMB) Race · Black or African American	35 Participants n=604 Participants	30 Participants n=594 Participants	111 Participants n=2167 Participants	11 Participants n=384 Participants	35 Participants n=585 Participants
Race (NIH/OMB) Race · White	270 Participants n=604 Participants	264 Participants n=594 Participants	952 Participants n=2167 Participants	150 Participants n=384 Participants	268 Participants n=585 Participants
Race (NIH/OMB) Race · More than one race	0 Participants n=604 Participants	0 Participants n=594 Participants	0 Participants n=2167 Participants	0 Participants n=384 Participants	0 Participants n=585 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	63 Participants n=604 Participants	60 Participants n=594 Participants	220 Participants n=2167 Participants	44 Participants n=384 Participants	53 Participants n=585 Participants
Region of Enrollment Brazil	25 Participants n=604 Participants	20 Participants n=594 Participants	81 Participants n=2167 Participants	11 Participants n=384 Participants	25 Participants n=585 Participants
Region of Enrollment China	214 Participants n=604 Participants	215 Participants n=594 Participants	795 Participants n=2167 Participants	156 Participants n=384 Participants	210 Participants n=585 Participants
Region of Enrollment Colombia	1 Participants n=604 Participants	1 Participants n=594 Participants	3 Participants n=2167 Participants	0 Participants n=384 Participants	1 Participants n=585 Participants
Region of Enrollment Czech Republic	34 Participants n=604 Participants	35 Participants n=594 Participants	127 Participants n=2167 Participants	25 Participants n=384 Participants	33 Participants n=585 Participants
Region of Enrollment Germany	56 Participants n=604 Participants	59 Participants n=594 Participants	196 Participants n=2167 Participants	28 Participants n=384 Participants	53 Participants n=585 Participants
Region of Enrollment United Kingdom	4 Participants n=604 Participants	1 Participants n=594 Participants	5 Participants n=2167 Participants	0 Participants n=384 Participants	0 Participants n=585 Participants
Region of Enrollment Greece	12 Participants n=604 Participants	13 Participants n=594 Participants	41 Participants n=2167 Participants	4 Participants n=384 Participants	12 Participants n=585 Participants
Region of Enrollment Israel	23 Participants n=604 Participants	26 Participants n=594 Participants	82 Participants n=2167 Participants	11 Participants n=384 Participants	22 Participants n=585 Participants
Region of Enrollment Mexico	32 Participants n=604 Participants	31 Participants n=594 Participants	123 Participants n=2167 Participants	27 Participants n=384 Participants	33 Participants n=585 Participants
Region of Enrollment Portugal	6 Participants n=604 Participants	2 Participants n=594 Participants	14 Participants n=2167 Participants	1 Participants n=384 Participants	5 Participants n=585 Participants
Region of Enrollment Russia	25 Participants n=604 Participants	24 Participants n=594 Participants	95 Participants n=2167 Participants	22 Participants n=384 Participants	24 Participants n=585 Participants
Region of Enrollment Slovakia	21 Participants n=604 Participants	18 Participants n=594 Participants	70 Participants n=2167 Participants	12 Participants n=384 Participants	19 Participants n=585 Participants
Region of Enrollment South Africa	77 Participants n=604 Participants	78 Participants n=594 Participants	295 Participants n=2167 Participants	60 Participants n=384 Participants	80 Participants n=585 Participants
Region of Enrollment Turkey	9 Participants n=604 Participants	10 Participants n=594 Participants	29 Participants n=2167 Participants	2 Participants n=384 Participants	8 Participants n=585 Participants
Region of Enrollment United States	65 Participants n=604 Participants	61 Participants n=594 Participants	211 Participants n=2167 Participants	25 Participants n=384 Participants	60 Participants n=585 Participants
Baseline Reversibility (%)	21.6 Percentage STANDARD_DEVIATION 17.2 • n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	22.0 Percentage STANDARD_DEVIATION 17.5 • n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	21.9 Percentage STANDARD_DEVIATION 17.6 • n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	22.3 Percentage STANDARD_DEVIATION 18.1 • n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	21.7 Percentage STANDARD_DEVIATION 17.9 • n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Baseline Pre-bronchodilator Percent Predicted FEV1 (%)	59.6 Percentage STANDARD_DEVIATION 12.4 • n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	59.3 Percentage STANDARD_DEVIATION 12.4 • n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	58.9 Percentage STANDARD_DEVIATION 12.6 • n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	58.6 Percentage STANDARD_DEVIATION 12.2 • n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	57.9 Percentage STANDARD_DEVIATION 13.3 • n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Baseline Severe Asthma Exacerbation History Within the Prior Year 0 exacerbations	311 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	302 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	1093 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	170 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	310 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Baseline Severe Asthma Exacerbation History Within the Prior Year 1 exacerbation	234 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	235 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	867 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	173 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	225 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Baseline Severe Asthma Exacerbation History Within the Prior Year ≥2 exacerbations	57 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	53 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	200 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	40 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	50 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Prior Inhaled Corticosteroid (ICS) Dose Low	2 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	3 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	8 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	0 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	3 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Prior Inhaled Corticosteroid (ICS) Dose Medium	440 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	428 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	1584 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	283 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	433 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Prior Inhaled Corticosteroid (ICS) Dose High	160 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	158 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	567 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	100 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	149 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.
Prior Inhaled Corticosteroid (ICS) Dose Missing	0 Participants n=602 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	1 Participants n=590 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	1 Participants n=2160 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	0 Participants n=383 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.	0 Participants n=585 Participants • Based on Efficacy Set, which excluded 7 subjects who were randomized across multiple Sponsor studies.

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=366 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=555 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=569 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=548 Participants Budesonide/formoterol fumarate pMDI
Change From Baseline in FEV1 AUC0-3 (L) at Week 24	0.374 Liters Standard Error 0.019	0.354 Liters Standard Error 0.015	0.219 Liters Standard Error 0.015	0.239 Liters Standard Error 0.015

PRIMARY outcome

Timeframe: Up to 52 Weeks

Population: 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).

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=725 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1179 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1208 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1192 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations	0.533 Exacerbations/Subject Years	0.541 Exacerbations/Subject Years	0.604 Exacerbations/Subject Years	0.662 Exacerbations/Subject Years

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=369 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=556 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=572 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=553 Participants Budesonide/formoterol fumarate pMDI
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24	0.186 Liters Standard Error 0.018	0.177 Liters Standard Error 0.015	0.069 Liters Standard Error 0.014	0.085 Liters Standard Error 0.015

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=363 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=553 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=573 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=564 Participants Budesonide/formoterol fumarate pMDI
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1	0.155 Liters Standard Deviation 0.211	0.180 Liters Standard Deviation 0.211	0.134 Liters Standard Deviation 0.202	0.143 Liters Standard Deviation 0.202

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=364 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=548 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=566 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=547 Participants Budesonide/formoterol fumarate pMDI
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	251 Participants	371 Participants	360 Participants	351 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=366 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=550 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=568 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=549 Participants Budesonide/formoterol fumarate pMDI
Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	263 Participants	388 Participants	387 Participants	380 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=358 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=529 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=543 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=536 Participants Budesonide/formoterol fumarate pMDI
Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24	205 Participants	297 Participants	301 Participants	289 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=357 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=530 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=536 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=536 Participants Budesonide/formoterol fumarate pMDI
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24	229 Participants	329 Participants	336 Participants	344 Participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=251 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=417 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=406 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=408 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline	0.733 Exacerbations/Subject Years	0.663 Exacerbations/Subject Years	0.780 Exacerbations/Subject Years	0.815 Exacerbations/Subject Years

SECONDARY outcome

Timeframe: Up to 52 Weeks

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=481 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=665 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=681 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=686 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1	0.707 Exacerbations/Subject Years	0.653 Exacerbations/Subject Years	0.710 Exacerbations/Subject Years	0.805 Exacerbations/Subject Years

SECONDARY outcome

Timeframe: Up to 52 weeks

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=723 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1175 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1204 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1188 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation Kaplan-Meier estimate at 24 weeks (%)	18.9 Percentage of participants	18.6 Percentage of participants	20.8 Percentage of participants	22.3 Percentage of participants
Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation Kaplan-Meier estimate at 52 weeks (%)	36.0 Percentage of participants	35.5 Percentage of participants	39.2 Percentage of participants	41.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=725 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1179 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1208 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1192 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations	0.545 Exacerbations/Subject Years	0.555 Exacerbations/Subject Years	0.626 Exacerbations/Subject Years	0.680 Exacerbations/Subject Years

SECONDARY outcome

Timeframe: Up to 52 weeks

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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=723 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1175 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1204 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1188 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation Kaplan-Meier estimate at 24 weeks (%)	19.1 Percentage of participants	19.1 Percentage of participants	21.4 Percentage of participants	22.9 Percentage of participants
Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation Kaplan-Meier estimate at 52 weeks (%)	36.3 Percentage of participants	36.2 Percentage of participants	40.0 Percentage of participants	42.3 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=691 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1117 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1148 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1126 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	458 Participants	741 Participants	733 Participants	693 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=693 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1121 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1155 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1129 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	486 Participants	769 Participants	781 Participants	741 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 μg BID n=671 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=1075 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=1106 Participants Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=1093 Participants Budesonide/formoterol fumarate pMDI
Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24	376 Participants	588 Participants	593 Participants	568 Participants

Adverse Events

BGF MDI 320/14.4/9.6 μg BID

Serious events: 31 serious events

Other events: 122 other events

Deaths: 0 deaths

BGF MDI 320/28.8/9.6 μg BID

Serious events: 41 serious events

Other events: 157 other events

Deaths: 3 deaths

BFF MDI 320/9.6 μg BID

Serious events: 49 serious events

Other events: 169 other events

Deaths: 3 deaths

Symbicort® 320/9 μg BID

Serious events: 36 serious events

Other events: 162 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BGF MDI 320/14.4/9.6 μg BID n=384 participants at risk Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=585 participants at risk Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=604 participants at risk Budesonide and formoterol fumarate MDI	Symbicort® 320/9 μg BID n=594 participants at risk Budesonide/formoterol fumarate pMDI
Infections and infestations COVID-19	7.6% 29/384 • Number of events 29 • 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.	7.4% 43/585 • Number of events 43 • 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.	6.3% 38/604 • Number of events 39 • 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.	6.4% 38/594 • Number of events 38 • 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.
Infections and infestations Nasopharyngitis	12.0% 46/384 • Number of events 53 • 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.	10.6% 62/585 • Number of events 87 • 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.	8.4% 51/604 • Number of events 66 • 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.	10.3% 61/594 • Number of events 82 • 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.
Infections and infestations Upper respiratory tract infection	15.1% 58/384 • Number of events 79 • 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.	12.6% 74/585 • Number of events 97 • 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.	15.4% 93/604 • Number of events 131 • 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.	14.0% 83/594 • Number of events 121 • 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.

Additional Information

Global Clinical Head

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER