Trial Outcomes & Findings for Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (NCT NCT04609878)

Last Updated: 2026-06-30

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

2274 participants

Primary outcome timeframe

Week 24

Results posted on

2026-06-30

Participant Flow

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.

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.

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® pMDI 320/9 μg BID Budesonide/formoterol fumarate pMDI
Overall Study STARTED	342	594	606	602
Overall Study COMPLETED	316	541	560	551
Overall Study NOT COMPLETED	26	53	46	51

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® pMDI 320/9 μg BID Budesonide/formoterol fumarate pMDI
Overall Study Withdrawal by Subject	12	30	29	28
Overall Study Physician Decision	3	3	8	4
Overall Study Lost to Follow-up	2	5	2	6
Overall Study Other/not specified	2	6	1	3
Overall Study Adverse Event	4	2	2	3
Overall Study Lack of Efficacy	1	1	1	3
Overall Study Death	1	1	1	2
Overall Study Withdrawal by parent/guardian	0	2	1	1
Overall Study Failure to meet randomization criteria	1	0	1	1
Overall Study Non-compliance with study drug	0	2	0	0
Overall Study Development of study-specific withdrawal criteria	0	1	0	0

Baseline Characteristics

Based on Efficacy Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGF MDI 320/14.4/9.6 μg BID n=342 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=594 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=606 Participants Budesonide and formoterol fumarate MDI	Symbicort® pMDI 320/9 μg BID n=602 Participants Budesonide/formoterol fumarate pMDI	Total n=2144 Participants Total of all reporting groups
Age, Categorical Age group (years) · <=18 years	10 Participants n=342 Participants	16 Participants n=594 Participants	22 Participants n=606 Participants	22 Participants n=602 Participants	70 Participants n=2144 Participants
Age, Categorical Age group (years) · Between 18 and 65 years	247 Participants n=342 Participants	437 Participants n=594 Participants	450 Participants n=606 Participants	432 Participants n=602 Participants	1566 Participants n=2144 Participants
Age, Categorical Age group (years) · >=65 years	85 Participants n=342 Participants	141 Participants n=594 Participants	134 Participants n=606 Participants	148 Participants n=602 Participants	508 Participants n=2144 Participants
Sex: Female, Male Sex · Female	228 Participants n=342 Participants	384 Participants n=594 Participants	376 Participants n=606 Participants	403 Participants n=602 Participants	1391 Participants n=2144 Participants
Sex: Female, Male Sex · Male	114 Participants n=342 Participants	210 Participants n=594 Participants	230 Participants n=606 Participants	199 Participants n=602 Participants	753 Participants n=2144 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	112 Participants n=342 Participants	184 Participants n=594 Participants	178 Participants n=606 Participants	190 Participants n=602 Participants	664 Participants n=2144 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	230 Participants n=342 Participants	410 Participants n=594 Participants	428 Participants n=606 Participants	412 Participants n=602 Participants	1480 Participants n=2144 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=342 Participants	0 Participants n=594 Participants	0 Participants n=606 Participants	0 Participants n=602 Participants	0 Participants n=2144 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	4 Participants n=342 Participants	2 Participants n=594 Participants	5 Participants n=606 Participants	4 Participants n=602 Participants	15 Participants n=2144 Participants
Race (NIH/OMB) Race · Asian	72 Participants n=342 Participants	147 Participants n=594 Participants	142 Participants n=606 Participants	157 Participants n=602 Participants	518 Participants n=2144 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=342 Participants	0 Participants n=594 Participants	0 Participants n=606 Participants	0 Participants n=602 Participants	0 Participants n=2144 Participants
Race (NIH/OMB) Race · Black or African American	9 Participants n=342 Participants	12 Participants n=594 Participants	15 Participants n=606 Participants	9 Participants n=602 Participants	45 Participants n=2144 Participants
Race (NIH/OMB) Race · White	216 Participants n=342 Participants	384 Participants n=594 Participants	397 Participants n=606 Participants	378 Participants n=602 Participants	1375 Participants n=2144 Participants
Race (NIH/OMB) Race · More than one race	41 Participants n=342 Participants	49 Participants n=594 Participants	47 Participants n=606 Participants	54 Participants n=602 Participants	191 Participants n=2144 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=342 Participants	0 Participants n=594 Participants	0 Participants n=606 Participants	0 Participants n=602 Participants	0 Participants n=2144 Participants
Region of Enrollment Argentina	59 Participants n=342 Participants	102 Participants n=594 Participants	100 Participants n=606 Participants	100 Participants n=602 Participants	361 Participants n=2144 Participants
Region of Enrollment Belgium	1 Participants n=342 Participants	0 Participants n=594 Participants	0 Participants n=606 Participants	1 Participants n=602 Participants	2 Participants n=2144 Participants
Region of Enrollment Bulgaria	51 Participants n=342 Participants	81 Participants n=594 Participants	85 Participants n=606 Participants	81 Participants n=602 Participants	298 Participants n=2144 Participants
Region of Enrollment Canada	10 Participants n=342 Participants	14 Participants n=594 Participants	15 Participants n=606 Participants	14 Participants n=602 Participants	53 Participants n=2144 Participants
Region of Enrollment Chile	11 Participants n=342 Participants	25 Participants n=594 Participants	25 Participants n=606 Participants	23 Participants n=602 Participants	84 Participants n=2144 Participants
Region of Enrollment Hungary	25 Participants n=342 Participants	36 Participants n=594 Participants	33 Participants n=606 Participants	36 Participants n=602 Participants	130 Participants n=2144 Participants
Region of Enrollment India	25 Participants n=342 Participants	37 Participants n=594 Participants	36 Participants n=606 Participants	42 Participants n=602 Participants	140 Participants n=2144 Participants
Region of Enrollment Italy	3 Participants n=342 Participants	5 Participants n=594 Participants	7 Participants n=606 Participants	6 Participants n=602 Participants	21 Participants n=2144 Participants
Region of Enrollment Japan	5 Participants n=342 Participants	18 Participants n=594 Participants	13 Participants n=606 Participants	16 Participants n=602 Participants	52 Participants n=2144 Participants
Region of Enrollment New Zealand	1 Participants n=342 Participants	0 Participants n=594 Participants	1 Participants n=606 Participants	0 Participants n=602 Participants	2 Participants n=2144 Participants
Region of Enrollment Peru	40 Participants n=342 Participants	42 Participants n=594 Participants	41 Participants n=606 Participants	41 Participants n=602 Participants	164 Participants n=2144 Participants
Region of Enrollment Philippines	10 Participants n=342 Participants	34 Participants n=594 Participants	32 Participants n=606 Participants	35 Participants n=602 Participants	111 Participants n=2144 Participants
Region of Enrollment Poland	22 Participants n=342 Participants	60 Participants n=594 Participants	59 Participants n=606 Participants	58 Participants n=602 Participants	199 Participants n=2144 Participants
Region of Enrollment Korea, Republic Of	7 Participants n=342 Participants	9 Participants n=594 Participants	10 Participants n=606 Participants	14 Participants n=602 Participants	40 Participants n=2144 Participants
Region of Enrollment Romania	11 Participants n=342 Participants	19 Participants n=594 Participants	22 Participants n=606 Participants	19 Participants n=602 Participants	71 Participants n=2144 Participants
Region of Enrollment Spain	4 Participants n=342 Participants	8 Participants n=594 Participants	11 Participants n=606 Participants	10 Participants n=602 Participants	33 Participants n=2144 Participants
Region of Enrollment Taiwan, China	5 Participants n=342 Participants	12 Participants n=594 Participants	10 Participants n=606 Participants	7 Participants n=602 Participants	34 Participants n=2144 Participants
Region of Enrollment Thailand	6 Participants n=342 Participants	12 Participants n=594 Participants	18 Participants n=606 Participants	14 Participants n=602 Participants	50 Participants n=2144 Participants
Region of Enrollment United States	35 Participants n=342 Participants	57 Participants n=594 Participants	69 Participants n=606 Participants	63 Participants n=602 Participants	224 Participants n=2144 Participants
Region of Enrollment Viet Nam	11 Participants n=342 Participants	23 Participants n=594 Participants	19 Participants n=606 Participants	22 Participants n=602 Participants	75 Participants n=2144 Participants
Baseline Reversibility (%)	24.5 Percentage STANDARD_DEVIATION 19.8 • n=342 Participants • Based on Efficacy Set	23.6 Percentage STANDARD_DEVIATION 19.9 • n=593 Participants • Based on Efficacy Set	22.5 Percentage STANDARD_DEVIATION 17.4 • n=606 Participants • Based on Efficacy Set	22.0 Percentage STANDARD_DEVIATION 16.9 • n=601 Participants • Based on Efficacy Set	23.0 Percentage STANDARD_DEVIATION 18.4 • n=2142 Participants • Based on Efficacy Set
Baseline Pre-bronchodilator Percent Predicted FEV1 (%)	58.6 Percentage STANDARD_DEVIATION 12.6 • n=342 Participants	58.3 Percentage STANDARD_DEVIATION 12.2 • n=594 Participants	59.3 Percentage STANDARD_DEVIATION 12.1 • n=606 Participants	58.5 Percentage STANDARD_DEVIATION 12.5 • n=602 Participants	58.7 Percentage STANDARD_DEVIATION 12.3 • n=2144 Participants
Baseline Severe Asthma Exacerbation History Within the Prior Year 0 exacerbations	74 Participants n=342 Participants	204 Participants n=594 Participants	216 Participants n=606 Participants	204 Participants n=602 Participants	698 Participants n=2144 Participants
Baseline Severe Asthma Exacerbation History Within the Prior Year 1 exacerbation	186 Participants n=342 Participants	275 Participants n=594 Participants	261 Participants n=606 Participants	272 Participants n=602 Participants	994 Participants n=2144 Participants
Baseline Severe Asthma Exacerbation History Within the Prior Year ≥2 exacerbations	82 Participants n=342 Participants	115 Participants n=594 Participants	129 Participants n=606 Participants	126 Participants n=602 Participants	452 Participants n=2144 Participants
Prior Inhaled Corticosteroid (ICS) Dose Low	9 Participants n=342 Participants	4 Participants n=594 Participants	3 Participants n=606 Participants	3 Participants n=602 Participants	19 Participants n=2144 Participants
Prior Inhaled Corticosteroid (ICS) Dose Medium	176 Participants n=342 Participants	351 Participants n=594 Participants	341 Participants n=606 Participants	344 Participants n=602 Participants	1212 Participants n=2144 Participants
Prior Inhaled Corticosteroid (ICS) Dose High	156 Participants n=342 Participants	239 Participants n=594 Participants	261 Participants n=606 Participants	255 Participants n=602 Participants	911 Participants n=2144 Participants
Prior Inhaled Corticosteroid (ICS) Dose Missing	1 Participants n=342 Participants	0 Participants n=594 Participants	1 Participants n=606 Participants	0 Participants n=602 Participants	2 Participants n=2144 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=580 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=329 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=575 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=580 Participants Budesonide and formoterol fumarate MDI
Change From Baseline in FEV1 AUC0-3 (L) at Week 24	0.220 Liters Standard Error 0.014	0.281 Liters Standard Error 0.018	0.316 Liters Standard Error 0.014	0.249 Liters Standard Error 0.014

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 D5982C00008 (NCT04609904).

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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=1192 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations	0.662 Exacerbations/Subject Years	0.533 Exacerbations/Subject Years	0.541 Exacerbations/Subject Years	0.604 Exacerbations/Subject Years

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=581 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=330 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=578 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=582 Participants Budesonide and formoterol fumarate MDI
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24	0.073 Liters Standard Error 0.013	0.119 Liters Standard Error 0.017	0.157 Liters Standard Error 0.013	0.115 Liters Standard Error 0.013

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=573 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=329 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=561 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=579 Participants Budesonide and formoterol fumarate MDI
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1	0.122 Liters Standard Deviation 0.182	0.129 Liters Standard Deviation 0.194	0.161 Liters Standard Deviation 0.194	0.143 Liters Standard Deviation 0.202

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=579 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=327 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=569 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=582 Participants Budesonide and formoterol fumarate MDI
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	342 Participants	207 Participants	370 Participants	373 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	Symbicort® pMDI 320/9 μg BID n=580 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=327 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=571 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=587 Participants Budesonide and formoterol fumarate MDI
Percentage of Responders in the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	361 Participants	223 Participants	381 Participants	394 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	Symbicort® pMDI 320/9 μg BID n=557 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=313 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=546 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=563 Participants Budesonide and formoterol fumarate MDI
Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24	279 Participants	171 Participants	291 Participants	292 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	Symbicort® pMDI 320/9 μg BID n=543 Participants Budesonide/formoterol fumarate pMDI	BGF MDI 320/14.4/9.6 μg BID n=319 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=545 Participants Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=554 Participants Budesonide and formoterol fumarate MDI
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24	298 Participants	181 Participants	346 Participants	310 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 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=408 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline	0.815 Exacerbations/Subject Years	0.733 Exacerbations/Subject Years	0.663 Exacerbations/Subject Years	0.780 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 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=686 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1	0.805 Exacerbations/Subject Years	0.707 Exacerbations/Subject Years	0.653 Exacerbations/Subject Years	0.710 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 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.

Outcome measures

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

SECONDARY outcome

Timeframe: Up to 52 weeks

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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=1192 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations	0.680 Exacerbations/Subject Years	0.545 Exacerbations/Subject Years	0.555 Exacerbations/Subject Years	0.626 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 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.

Outcome measures

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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=1126 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	693 Participants	458 Participants	741 Participants	733 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=1129 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	741 Participants	486 Participants	769 Participants	781 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Symbicort® pMDI 320/9 μg BID n=1093 Participants Budesonide/formoterol fumarate pMDI	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
Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24	568 Participants	376 Participants	588 Participants	593 Participants

Adverse Events

BGF MD I320/14.4/9.6 μg BID

Serious events: 18 serious events

Other events: 81 other events

Deaths: 1 deaths

BGF MDI 320/28.8/9.6 μg BID

Serious events: 32 serious events

Other events: 109 other events

Deaths: 1 deaths

BFF MDI 320/9.6 μg BID

Serious events: 34 serious events

Other events: 123 other events

Deaths: 1 deaths

Symbicort® pMDI 320/9 μg BID

Serious events: 32 serious events

Other events: 119 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BGF MD I320/14.4/9.6 μg BID n=342 participants at risk Budesonide, glycopyrronium, and formoterol fumarate MDI	BGF MDI 320/28.8/9.6 μg BID n=594 participants at risk Budesonide, glycopyrronium, and formoterol fumarate MDI	BFF MDI 320/9.6 μg BID n=606 participants at risk Budesonide and formoterol fumarate MDI	Symbicort® pMDI 320/9 μg BID n=602 participants at risk Budesonide/formoterol fumarate pMDI
Infections and infestations COVID-19	8.2% 28/342 • Number of events 28 • 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.	5.1% 30/594 • Number of events 31 • 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.	5.0% 30/606 • Number of events 30 • 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.	5.5% 33/602 • Number of events 34 • 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	10.8% 37/342 • Number of events 40 • 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.	8.2% 49/594 • Number of events 55 • 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% 51/606 • Number of events 57 • 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.	8.6% 52/602 • Number of events 60 • 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	6.1% 21/342 • Number of events 36 • 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.	7.2% 43/594 • Number of events 65 • 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.	8.6% 52/606 • Number of events 73 • 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.	6.5% 39/602 • Number of events 56 • 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