A Study Testing the Superiority of CHF 1535 pMDI 800/24µg... | NCT05292586

Description Module

Detailed Description

This was a phase III, multicenter, randomized, double-blind active controlled 2-arm parallel group to compare superiority of CHF 1535 pressurised metered dose inhaler (pMDI) compared with CHF 718 pMDI, in subjects with asthma on medium or high dose inhaled corticosteroids, with regard to change from baseline in forced expiratory volume in the first second (FEV1) Area under the Curve Calculated Between Time 0 and 12 Hours (AUC0-12h) at Week 12.

After screening, eligible subjects entered a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose inhaled corticosteroid (ICS) or medium dose ICS-long-acting β2-adrenergic receptor agonists (LABA) prior to the study, received CHF 718 pMDI 100µg 2 inhalations twice daily (BID) i.e. total daily dose (TDD) 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study received CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period.

Following the run-in period, eligible subjects were randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V), (V0-V5) and a follow-up call (V6) were performed during the study.

During the study, daily symptoms, rescue medication use, and compliance with the study drug were recorded via a subject-specific electronic diary (eDiary). Concomitant medications and adverse events (AEs) were assessed and recorded throughout the study. Vital signs measurements, physical exam, 12-lead electrocardiogram (ECG), peak expiratory flow (PEF), and spirometry measurements, including serial spirometry were performed and recorded. Symptoms were assessed using disease specific questionnaires. Routine hematology, blood chemistry, and urine pregnancy testing were performed before enrolment and at the end of study.

CHF 1535 pMDI = 200/6 μg pressurised metered dose inhaler (fixed combination of extrafine beclomethasone dipropionate [BDP] plus formoterol fumarate [FF]).

CHF 718 pMDI = 100 μg pressurised metered dose inhaler (extrafine beclomethasone dipropionate [BDP]).

Label	Type	Description	Intervention Names
CHF 1535 pMDI	Experimental	CHF 1535 pMDI 800/24µg TDD	Drug: Beclomethasone Dipropionate/Formoterol Fumarate
CHF 718 pMDI	Active Comparator	CHF 718 pMDI 800µg TDD	Drug: Beclomethasone Dipropionate

Name	Type	Description	Arm Group Labels	Other Names
Beclomethasone Dipropionate/Formoterol Fumarate	Drug	Available in pressurized inhalation solution BDP/FF 200/6 µg	CHF 1535 pMDI

Measure	Description	Time Frame
1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12	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	Baseline (pre-dose on Week 0) and Week 12.

Measure	Description	Time Frame
2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at 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	Baseline (pre-dose on Week 0) and Week 12.

Eligibility Module

Eligibility Criteria

Inclusion Criteria (IC):

Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
Sex and age: Male or female aged ≥18 and ≤75 years.
Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.

Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.
Female subjects:

a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).

b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.

Exclusion Criteria:

Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
Poor compliance with run-in medication or eDiary completion <50% before randomization.
History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease [GOLD] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
E-cigarette status: Current e-cigarettes users at the time of the screening visit.
Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-immunoglobulin E (IgE), anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
Participating in other investigational trial: Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
Spacer: The need to use a spacer for correct self-administration of a pMDI.

Name	Affiliation	Role
Steven F. Weinstein, M.D.	Allergy and Asthma Specialists Medical Group and Research Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Chiesi Clinical Trial Site 840858		Mobile	Alabama	36608	United States
Chiesi Clinical Trial Site 840895

PubMed Identifier	Type	Citation	Retractions
33329598	Background	Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Front Immunol. 2020 Nov 30;11:603312. doi: 10.3389/fimmu.2020.603312. eCollection 2020.
30406948	Background	Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.

ID	Title	Description
FG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
FG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 1, 2023	Jun 19, 2025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG0000.279(0.248 to 0.309) OG0010.174(0.143 to 0.206)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	1_Change from baseline 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).	ANCOVA		<0.001		Adjusted mean difference	0.104			2-Sided	95	0.061	0.148					Superiority

Secondary

2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Units

Secondary

3_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 0

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.

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Units	Counts

Secondary

4_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

5_Change From Baseline in Trough FEV1 at 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Units

Secondary

6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

8_Proportion of Trough FEV1 Responders at 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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

9_Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter/min

Baseline (Week 0) to Week 12.

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

10_Change From Baseline in Average Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

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

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

liter/min

Baseline (Week 0) to Week 12.

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

11_Change From Baseline in ACQ-7 Score and ACQ-5 Score at 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:

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

score

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg

Secondary

12_Change From Baseline in Percentage of Rescue Medication-free Days Over the 12-Week Treatment Period

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.

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

percentage of days

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Secondary

13_Change From Baseline in Percentage of Asthma Symptom-free Days Over the 12-Week Treatment Period

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.

Intention-to-treat (ITT) population: all randomised subjects who received at least one administration of the study drug.

Posted

Least Squares Mean

95% Confidence Interval

percentage of days

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

ID	Title	Description
OG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
OG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0013 events3 affected280 at risk
Bronchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events3 affected280 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected283 at risk EG0013 events3 affected280 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected283 at risk EG0017 events7 affected280 at risk
Oral candidiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0015 events5 affected280 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected283 at risk EG0019 events8 affected280 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0014 events4 affected280 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected283 at risk EG0010 events0 affected280 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0015 events5 affected280 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0008 events6 affected283 at risk EG00115 events14 affected280 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected283 at risk EG0012 events1 affected280 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0010 events0 affected280 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013258	Steroids, Chlorinated
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines

ID	Title	Description
BG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg
BG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CHF 1535 pMDI	CHF 1535 pMDI 800/24µg TDD Beclomethasone Dipropionate/Formoterol Fumarate: pressurized inhalation solution BDP/FF 200/6 µg	0	283	3	283	44	283
EG001	CHF 718 pMDI	CHF 718 pMDI 800µg TDD Beclomethasone Dipropionate: pressurized inhalation solution BDP 100 µg	0	280	0	280	53	280

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteomyelitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected280 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected280 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected280 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected280 at risk
Thoracic spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected280 at risk
Spinal cord compression	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected280 at risk