Trial Outcomes & Findings for A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (NCT NCT05292586)

Last Updated: 2025-09-04

Results Overview

The pre-dose FEV1 at baseline (i.e. pre-dose on Week 0 \[Visit 2\]) and the FEV1 AUC0-12h normalised by time at Week 12 (Visit 5) are presented by treatment group in the ITT population, as change from baseline. AUC0=12h Area under the curve calculated between time 0 and 12 hours

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1377 participants

Primary outcome timeframe

Baseline (pre-dose on Week 0) and Week 12.

Results posted on

2025-09-04

Participant Flow

Overall, 1377 participants were enrolled into the study; of these, 576 met eligibility criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	CHF 1535 pMDI CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
Overall Study STARTED	287	289
Overall Study COMPLETED	276	267
Overall Study NOT COMPLETED	11	22

Reasons for withdrawal

Reasons for withdrawal
Measure	CHF 1535 pMDI CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
Overall Study Withdrawal by Subject	3	10
Overall Study Randomization error	3	7
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	0	1
Overall Study Patient refused treatment	1	0
Overall Study Patient could not travel to the study site	1	0
Overall Study Technical issues with the masterscope	0	3
Overall Study Patient moved to a different state	0	1

Baseline Characteristics

Data presented are for the number of subjects with available data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHF 1535 pMDI n=283 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg	Total n=563 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=283 Participants	0 Participants n=280 Participants	0 Participants n=563 Participants
Age, Categorical Between 18 and 65 years	231 Participants n=283 Participants	237 Participants n=280 Participants	468 Participants n=563 Participants
Age, Categorical >=65 years	52 Participants n=283 Participants	43 Participants n=280 Participants	95 Participants n=563 Participants
Age, Continuous	51.6 years STANDARD_DEVIATION 14.1 • n=283 Participants	50.3 years STANDARD_DEVIATION 14.1 • n=280 Participants	50.9 years STANDARD_DEVIATION 14.1 • n=563 Participants
Sex: Female, Male Female	210 Participants n=283 Participants	202 Participants n=280 Participants	412 Participants n=563 Participants
Sex: Female, Male Male	73 Participants n=283 Participants	78 Participants n=280 Participants	151 Participants n=563 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	154 Participants n=283 Participants	165 Participants n=280 Participants	319 Participants n=563 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=283 Participants	113 Participants n=280 Participants	242 Participants n=563 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=283 Participants	2 Participants n=280 Participants	2 Participants n=563 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=283 Participants	1 Participants n=280 Participants	2 Participants n=563 Participants
Race (NIH/OMB) Asian	3 Participants n=283 Participants	6 Participants n=280 Participants	9 Participants n=563 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=283 Participants	1 Participants n=280 Participants	2 Participants n=563 Participants
Race (NIH/OMB) Black or African American	59 Participants n=283 Participants	49 Participants n=280 Participants	108 Participants n=563 Participants
Race (NIH/OMB) White	216 Participants n=283 Participants	220 Participants n=280 Participants	436 Participants n=563 Participants
Race (NIH/OMB) More than one race	2 Participants n=283 Participants	1 Participants n=280 Participants	3 Participants n=563 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=283 Participants	2 Participants n=280 Participants	3 Participants n=563 Participants
Region of Enrollment United States	283 Participants n=283 Participants	280 Participants n=280 Participants	563 Participants n=563 Participants
Body Mass Index (BMI)	30.90 kg/m^2 STANDARD_DEVIATION 6.93 • n=283 Participants	30.86 kg/m^2 STANDARD_DEVIATION 7.27 • n=280 Participants	30.88 kg/m^2 STANDARD_DEVIATION 7.09 • n=563 Participants
Time since first asthma diagnosis	474.6 months STANDARD_DEVIATION 173.6 • n=283 Participants	468.4 months STANDARD_DEVIATION 180.9 • n=280 Participants	471.5 months STANDARD_DEVIATION 177.1 • n=563 Participants
Asthma medication at study entry Inhaled Corticosteroid/Long-acting β2-adrenergic Receptor Agonists (ICS/LABA) combination	234 Participants n=283 Participants	230 Participants n=280 Participants	464 Participants n=563 Participants
Asthma medication at study entry ICS/LABA fixed combination	228 Participants n=283 Participants	221 Participants n=280 Participants	449 Participants n=563 Participants
Asthma medication at study entry ICS+LABA free combination	6 Participants n=283 Participants	9 Participants n=280 Participants	15 Participants n=563 Participants
Asthma medication at study entry High-dose ICS	3 Participants n=283 Participants	5 Participants n=280 Participants	8 Participants n=563 Participants
Asthma medication at study entry Medium-dose ICS	46 Participants n=283 Participants	45 Participants n=280 Participants	91 Participants n=563 Participants
Number of asthma exacerbations in the 4 weeks prior to screening 0	283 Participants n=283 Participants	280 Participants n=280 Participants	563 Participants n=563 Participants
Number of asthma exacerbations in the 4 weeks prior to screening 1+	0 Participants n=283 Participants	0 Participants n=280 Participants	0 Participants n=563 Participants
Time since last documented exacerbation	52.4 months STANDARD_DEVIATION 85.4 • n=43 Participants • Data presented are for the number of subjects with available data.	43.3 months STANDARD_DEVIATION 87.9 • n=53 Participants • Data presented are for the number of subjects with available data.	47.3 months STANDARD_DEVIATION 86.5 • n=96 Participants • Data presented are for the number of subjects with available data.
Treatment of the most recent exacerbation Systemic corticosteroids	35 Participants n=37 Participants • Data presented are for the number of subjects with available data.	43 Participants n=45 Participants • Data presented are for the number of subjects with available data.	78 Participants n=82 Participants • Data presented are for the number of subjects with available data.
Treatment of the most recent exacerbation Hospitalisation	1 Participants n=37 Participants • Data presented are for the number of subjects with available data.	0 Participants n=45 Participants • Data presented are for the number of subjects with available data.	1 Participants n=82 Participants • Data presented are for the number of subjects with available data.
Treatment of the most recent exacerbation Emergency room	12 Participants n=37 Participants • Data presented are for the number of subjects with available data.	7 Participants n=45 Participants • Data presented are for the number of subjects with available data.	19 Participants n=82 Participants • Data presented are for the number of subjects with available data.
Smoking status at screening Non-smoker	250 Participants n=283 Participants	244 Participants n=280 Participants	494 Participants n=563 Participants
Smoking status at screening Ex-smoker	33 Participants n=283 Participants	36 Participants n=280 Participants	69 Participants n=563 Participants
Smoking status at screening Current smoker	0 Participants n=283 Participants	0 Participants n=280 Participants	0 Participants n=563 Participants
Smoking duration	13.58 years STANDARD_DEVIATION 10.00 • n=33 Participants • Data available only for ex-smokers.	12.67 years STANDARD_DEVIATION 9.29 • n=36 Participants • Data available only for ex-smokers.	13.11 years STANDARD_DEVIATION 9.57 • n=69 Participants • Data available only for ex-smokers.
Number of pack-years	2.9 pack-years STANDARD_DEVIATION 2.7 • n=33 Participants • Data available only for ex-smokers.	3.7 pack-years STANDARD_DEVIATION 3.1 • n=36 Participants • Data available only for ex-smokers.	3.3 pack-years STANDARD_DEVIATION 2.9 • n=69 Participants • Data available only for ex-smokers.
Electronic cigarettes - Smoking status at screening Non-smoker	283 Participants n=283 Participants	280 Participants n=280 Participants	563 Participants n=563 Participants
Electronic cigarettes - Smoking status at screening Ex-smoker	0 Participants n=283 Participants	0 Participants n=280 Participants	0 Participants n=563 Participants
Electronic cigarettes - Smoking status at screening Current smoker	0 Participants n=283 Participants	0 Participants n=280 Participants	0 Participants n=563 Participants
FEV1 -- At baseline	1.850 liters STANDARD_DEVIATION 0.535 • n=283 Participants • Data presented are for the number of subjects with available data.	1.860 liters STANDARD_DEVIATION 0.559 • n=279 Participants • Data presented are for the number of subjects with available data.	1.855 liters STANDARD_DEVIATION 0.546 • n=562 Participants • Data presented are for the number of subjects with available data.
FEV1 (% of predicted normal value) at baseline	64.104 percent of predicted STANDARD_DEVIATION 10.651 • n=283 Participants • Data presented are for the number of subjects with available data.	63.033 percent of predicted STANDARD_DEVIATION 10.739 • n=279 Participants • Data presented are for the number of subjects with available data.	63.572 percent of predicted STANDARD_DEVIATION 10.698 • n=562 Participants • Data presented are for the number of subjects with available data.
FVC at baseline	2.661 liters STANDARD_DEVIATION 0.899 • n=283 Participants	2.614 liters STANDARD_DEVIATION 0.945 • n=280 Participants	2.637 liters STANDARD_DEVIATION 0.922 • n=563 Participants
ACQ score at baseline ACQ-7	1.30 score STANDARD_DEVIATION 0.88 • n=278 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©	1.25 score STANDARD_DEVIATION 0.87 • n=276 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©	1.28 score STANDARD_DEVIATION 0.88 • n=554 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©
ACQ score at baseline ACQ-5	0.92 score STANDARD_DEVIATION 0.95 • n=283 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©	0.88 score STANDARD_DEVIATION 0.98 • n=280 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©	0.90 score STANDARD_DEVIATION 0.96 • n=563 Participants • Data presented are for the number of subjects with available data. ACQ=Asthma Control Questionnaire©

PRIMARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

Population: Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug. Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group).

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=272 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=258 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12	0.279 liter Interval 0.248 to 0.309	0.174 liter Interval 0.143 to 0.206

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The peak FEV1 at baseline (i.e. pre-dose on Week 0 \[V2\]) and the peak FEV1 within the first 3 hours post-dose at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline. FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=276 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=264 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 12	0.419 liter Interval 0.385 to 0.453	0.295 liter Interval 0.26 to 0.33

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The pre-dose FEV1 at baseline (i.e. pre-dose on Week 0 \[V2\]) and the FEV1 AUC0-12h normalised by time at Week 0 (V2, post-dose) are presented by treatment group in the ITT population, as change from baseline.

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=278 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=277 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
3_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 0	0.250 liter Interval 0.223 to 0.276	0.149 liter Interval 0.122 to 0.175

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and 3 h post dose on Week 0.

The peak FEV1 at baseline (i.e. pre-dose on Week 0 \[V2\]) and the peak FEV1 within the first 3 hours post-dose at Week 0 (V2, post-dose) are presented by treatment group in the ITT population, as change from baseline. FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=278 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=277 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
4_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 0	0.374 liter Interval 0.345 to 0.404	0.262 liter Interval 0.233 to 0.291

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The trough FEV1 at baseline (i.e. pre-dose on Week 0 \[V2\]), the trough FEV1 at Week 12 (V5) and the change from baseline in trough FEV1 at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline. FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=274 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=264 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
5_Change From Baseline in Trough FEV1 at Week 12	0.212 liter Interval 0.179 to 0.244	0.143 liter Interval 0.11 to 0.176

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The pre-dose MORNING FEV1 at baseline (i.e. pre-dose on Week 0 \[V2\]) and the pre-dose morning FEV1 at Week 4 (V3), Week 8 (V4) and Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline. FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=283 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 12 Week 4 (V3)	0.152 liter Interval 0.121 to 0.182	0.107 liter Interval 0.076 to 0.139
6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 12 Week 8 (V4)	0.188 liter Interval 0.154 to 0.222	0.147 liter Interval 0.113 to 0.182
6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 12 Week 12 (V5)	0.162 liter Interval 0.132 to 0.193	0.120 liter Interval 0.088 to 0.151

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The proportion of pre-dose MORNING FEV1 responders at Week 4 (V3), Week 8 (V4) and Week 12 (V5) are presented by treatment group in the ITT population. The proportion of subjects classified as pre-dose morning FEV1 responders (i.e. those subjects who had change from baseline in pre-dose morning FEV1 ≥100 mL). FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=283 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 12 Week 4 (V3)	154 Participants	130 Participants
7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 12 Week 8 (V4)	162 Participants	141 Participants
7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 12 Week 12 (V5)	162 Participants	125 Participants

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The proportion of trough FEV1 responders at Week 12 (V5) are presented by treatment group in the ITT population. The proportion of subjects classified as trough FEV1 responders (i.e. those subjects who had change from baseline in trough FEV1 ≥100 mL). FEV1=Forced Expiratory Volume in the First Second

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=283 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
8_Proportion of Trough FEV1 Responders at Week 12	181 Participants	136 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 12.

The average MORNING PEF at baseline (i.e. average morning "Best PEF" values during the run-in period, over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population), as change from baseline. PEF=Peak Expiratory Flow

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=279 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=277 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
9_Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period	13.45 liter/min Interval 9.58 to 17.32	4.67 liter/min Interval 0.77 to 8.56

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 12.

The average EVENING PEF at baseline (i.e. average evening "Best PEF" values during the run-in period, see Section 9.7.1.4), over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline. PEF=Peak Expiratory Flow

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=280 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=277 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
10_Change From Baseline in Average Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period	10.27 liter/min Interval 6.46 to 14.08	1.54 liter/min Interval -2.31 to 5.38

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The ACQ-7 and ACQ-5 scores at baseline (i.e. pre-dose on Week 0 \[V2\]) and at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline; only patients who provided required data at baseline and at specified times are included in the calculation. Asthma control was evaluated during the treatment period (Week 0 to Week 12 \[V2-V5\])/end of treatment (ET) if applicable, using ACQ-7; first 6 items refer to symptoms and rescue use in the previous 7 days. The 7th item, filled in by the clinical staff, was the FEV1 (% predicted) recorded at 15 min pre-dose, measured at each visit during the treatment period. ACQ-5 has 5 items on adequacy of asthma control. ACQ-7: Assess asthma symptoms over last 7 days (night-time awakenings due to symptoms, morning symptoms, activity limitation, shortness of breath, wheezing), average daily rescue medication use, and current FEV1 percent predicted. Score scale: 0=totally controlled; 6=severely uncontrolled.

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=283 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
11_Change From Baseline in ACQ-7 Score and ACQ-5 Score at Week 12 ACQ-7	-0.414 score Interval -0.484 to -0.345	-0.302 score Interval -0.373 to -0.231
11_Change From Baseline in ACQ-7 Score and ACQ-5 Score at Week 12 ACQ-5	-0.413 score Interval -0.481 to -0.345	-0.433 score Interval -0.503 to -0.364

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The percentage of rescue medication-free days at baseline (i.e. percentage of days during the run-in period with no rescue medication), over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline.

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=282 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=279 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
12_Change From Baseline in Percentage of Rescue Medication-free Days Over the 12-Week Treatment Period	17.923 percentage of days Interval 15.457 to 20.388	14.103 percentage of days Interval 11.617 to 16.589

SECONDARY outcome

Timeframe: Baseline (pre-dose on Week 0) and Week 12.

The percentage of asthma symptom-free days at baseline (i.e. percentage of days during the run-in period with no asthma symptom, over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline.

Outcome measures

Outcome measures
Measure	CHF 1535 pMDI n=223 Participants CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=212 Participants CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
13_Change From Baseline in Percentage of Asthma Symptom-free Days Over the 12-Week Treatment Period	20.872 percentage of days Interval 17.908 to 23.836	17.092 percentage of days Interval 14.098 to 20.086

Adverse Events

CHF 1535 pMDI

Serious events: 3 serious events

Other events: 44 other events

Deaths: 0 deaths

CHF 718 pMDI

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CHF 1535 pMDI n=283 participants at risk CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 participants at risk CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
Infections and infestations Osteomyelitis	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations Pneumonia influenzal	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.35% 1/283 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Injury, poisoning and procedural complications Spinal cord injury	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Musculoskeletal and connective tissue disorders Thoracic spinal stenosis	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Nervous system disorders Spinal cord compression	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.

Other adverse events

Other adverse events
Measure	CHF 1535 pMDI n=283 participants at risk CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	CHF 718 pMDI n=280 participants at risk CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
Gastrointestinal disorders Vomiting	0.35% 1/283 • Number of events 1 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.1% 3/280 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations Bronchitis	0.00% 0/283 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.1% 3/280 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations COVID-19	1.4% 4/283 • Number of events 4 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.1% 3/280 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations Nasopharyngitis	2.8% 8/283 • Number of events 8 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	2.5% 7/280 • Number of events 7 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations Oral candidiasis	1.1% 3/283 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.8% 5/280 • Number of events 5 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Infections and infestations Upper respiratory tract infection	2.1% 6/283 • Number of events 6 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	2.9% 8/280 • Number of events 9 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Musculoskeletal and connective tissue disorders Back pain	1.1% 3/283 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.4% 4/280 • Number of events 4 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	1.8% 5/283 • Number of events 5 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Nervous system disorders Headache	1.1% 3/283 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	1.8% 5/280 • Number of events 5 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Respiratory, thoracic and mediastinal disorders Asthma	2.1% 6/283 • Number of events 8 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	5.0% 14/280 • Number of events 15 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 5/283 • Number of events 5 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.36% 1/280 • Number of events 2 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.
Vascular disorders Hypertension	1.1% 3/283 • Number of events 3 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.	0.00% 0/280 • Adverse events (AE) were reported from the time of patient informed consent signature until study completion at week 12 or at study discontinuation. Treatment-emergent AEs (TEAEs) were defined as AEs with date of first randomised study treatment intake as AE onset date or the date of study completion/discontinuation. Safety population: all randomised subjects who received at least one administration of the study drug.

Additional Information

Clinical Trial Transparency

Chiesi Farmaceutici S.p.A.

Phone: + 39 0521 2791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor to Chiesi before submission.
Publication restrictions are in place

Restriction type: OTHER