Pharmacokinetics, Safety and Tolerability of Twice-Daily... | NCT03276078

ID	Type	Description	Link
M-AS464-01	Other Identifier	Clinical Trial Protocol Code

Label	Type	Description	Intervention Names
Aclidinium Bromide/Formoterol Fumarate 400/12μg BID	Experimental	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).	Drug: Aclidinium Bromide/Formoterol Fumarate 400/12μg BID

Name	Type	Description	Arm Group Labels	Other Names
Aclidinium Bromide/Formoterol Fumarate 400/12μg BID	Drug	Aclidinium bromide/formoterol fumarate 400/12μg administered by inhalation via the Genuair® multidose dry powder inhaler, twice daily (morning and evening) for 5 days

Measure	Description	Time Frame
Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	Observed maximum concentration, taken directly from the individual concentration-time curve (first dose).	Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Tmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	Time to maximum concentration (h), taken directly from the individual concentration-time curve (first dose).	Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Cmin of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	Minimum plasma drug concentration at the end of the dosing interval (first dose), where possible.	Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
AUC(Last) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration.	Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
AUC(Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	Area under the plasma concentration curve during the first dosing interval, tau (first dose).	Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Css,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Measure	Description	Time Frame
Adverse Events (AEs)/Serious AEs (SAEs)	Assessment of the safety in terms of the incidences of AEs/SAEs after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.	Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to Blood Pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to communicate with medical team and staff, willing to participate in the trial, willing to give written informed consent, and comply with the trial procedures and restrictions.
Chinese men or non-pregnant, non-lactating women, aged ≥40 years old at Visit 1 (Screening).
Patients with a diagnosis of COPD (GOLD guidelines) for a period of at least 6 months prior to Visit 1 (screening).
Current or former smokers with a smoking history of ≥10 pack-years.
Patients with moderate to severe stable COPD (Stage II or Stage III, according to GOLD Guidelines) at Visit 1: post-bronchodilator FEV1 ≥30% and <80% and post-bronchodilator FEV1/FVC <70%.
Must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Visit 1 (Screening).

Exclusion Criteria:

Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff) or patients employed by or relatives of the employees of the site or sponsor.
Previous enrolment or randomisation in the present study.
History or current diagnosis of asthma.
Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period.
Patients hospitalized for COPD exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period.
Use of long-term oxygen therapy ≥15 hours per day.
Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, inhaled medication, or any component thereof.
Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic nonstable prostatic hypertrophy.
Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypothyroidism or hyperthyroidism, hypokalaemia, hyperadrenergic state, or uncontrolled or untreated hypertension.
Clinically significant cardiovascular conditions.
Patient with resting systolic blood pressure ≥160 mmHg, a resting diastolic blood pressure ≥100 mmHg, or a resting heart rate ≤50 bpm or ≥100 bpm at Visit 1 (Screening) or/and at Visit 2 (Day -1 to Day 7).
Have a body mass index (BMI) ≥40 kg/m2
Electrocardiogram (ECG) at Screening or Day -1 showing corrected QT interval (QTc) using Fridericia's correction (QTcF) >470 msec.
Patients with clinically relevant abnormalities in the results of the laboratory tests, ECG parameters (other than QTcF), or in the physical examination at Visit 1, except those related to COPD.
Positive results for drugs of abuse in the urine at Visit 1 (Screening).
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody and/or human immunodeficiency virus (HIV) I antibodies at Visit 1 (Screening).
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
Any other serious or uncontrolled physical or mental condition/disease.
Patient with a history (within 2 years prior to Visit 1 [Screening]) of drug and/or alcohol abuse that may prevent trial compliance based on investigator judgment.
Taken any medication within 14 days before the first dose of IP, or hormonal drug products and traditional Chinese medicines within 30 days before the first dose of IP, with the exception of allowed medications listed in the study protocol.
Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma drawn within 60 days of Day 1 at Visit 2.
Have participated in a blood/plasma donation or blood loss greater than 400 mL within 90 days or greater than 200 mL within 30 days prior to Visit 1 (Screening).
Have any clinical condition that might affect the absorption, distribution, biotransformation, or excretion of Aclidinium Bromide/Formoterol Fumarate.
Have consumed caffeine or any grapefruit-containing products within 48 hours or alcohol within 72 hours before Day -1 at Visit 2.
Inability to be venipunctured or tolerate venous access as determined by the investigator or designee.
Inability to use a multidose DPI.
Subjects unable to give their consent, or subjects of consenting age but under guardianship, or vulnerable subjects.
In the opinion of the PI, subjects who are unlikely to comply with the protocol requirements, instructions, and trial-related restrictions.
Previously taken Aclidinium or previously participated in an investigational study of Aclidinium within 6 months of Day 1

Name	Affiliation	Role
Zhenxiang Yu	Pneumology Department, The First Hospital of Jilin University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Changchun		130021	China

PubMed Identifier	Type	Citation	Retractions
35133636	Derived	Zhang H, Daoud SZ, Gillen MS, Calderon N, Heijer M, Molins E, Garcia-Gil E, Chen H, Li Q, Liu C, Ding Y. An Evaluation of the Pharmacokinetics, Safety, and Tolerability of Aclidinium/Formoterol Fixed-Dose Combination Administered in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Drugs R D. 2022 Mar;22(1):35-42. doi: 10.1007/s40268-021-00374-z. Epub 2022 Feb 8.

Label	URL
Statistical Analysis Plan (SAP)	View source

ID	Title	Description
FG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 3, 2018	May 14, 2019

ID	Title	Description
BG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	BG00020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).

Observed maximum concentration, taken directly from the individual concentration-time curve (first dose).

Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG00020

Title

Denominators

Categories

Aclidinium Bromide

Title	Measurements
	OG00045.82± 84.54

LAS34850

Title	Measurements
	OG0003149± 55.56

LAS34823

Primary

Tmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).

Time to maximum concentration (h), taken directly from the individual concentration-time curve (first dose).

Posted

Median

Full Range

hours

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Cmin of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).

Minimum plasma drug concentration at the end of the dosing interval (first dose), where possible.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

AUC(Last) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).

Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg*hour/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

AUC(Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).

Area under the plasma concentration curve during the first dosing interval, tau (first dose).

Posted

Geometric Mean

Geometric Coefficient of Variation

pg*hour/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Css,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Observed maximum concentration, taken directly from the individual concentration-time curve at steady state.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Css,Min of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Observed minimum concentration, taken directly from the individual concentration-time curve within a dosing interval on Day 5.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Tss,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Time to maximum concentration (h), taken directly from the individual concentration-time curve at steady state.

Posted

Median

Full Range

hours

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Terminal rate constant, estimated by log-linear least square regression of the terminal part of the concentration-time curve.

Posted

Mean

Standard Deviation

1/hours

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

t½λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Terminal half-life (h), estimated as (ln2)/λz.

Posted

Mean

Standard Deviation

hours

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

AUC(ss,Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Area under the plasma concentration curve during the dosing interval, tau at steady state.

Posted

Geometric Mean

Geometric Coefficient of Variation

pg*hour/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

CL/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).

Apparent plasma clearance for parent drug estimated as dose divided by AUCss

Posted

Mean

Standard Deviation

L/hour

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Vz/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).

Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz.

Posted

Mean

Standard Deviation

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Cav of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Average plasma concentration during a dosing interval, estimated as AUC(ss,tau)/12

Posted

Geometric Mean

Geometric Coefficient of Variation

pg/mL

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

%Fluctuation of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Fluctuation index during a dosing interval estimated as 100*(Cmax-Cmin)/Cav (%).

Posted

Mean

Standard Deviation

Percentage

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Rac(Cmax) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Accumulation ratio for Cmax estimated as Css,max on Day 5/Cmax on Day 1

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Rac[AUC(Tau)] of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Accumulation ratio for AUC(tau) estimated as AUC(ss,tau) on Day 5/AUC(tau) on Day 1

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Primary

Rac(Cmin) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).

Accumulation ratio for Cmin estimated as Css,min on Day 5/Cmin on Day 1.

Additional parameters may be determined where appropriate.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Adverse Events (AEs)/Serious AEs (SAEs)

Assessment of the safety in terms of the incidences of AEs/SAEs after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of the investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Treatment-emergent AEs Related to Blood Pressure

Assessment of the safety in terms of notable changes from baseline in blood pressure after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Treatment-emergent AEs Related to Clinical Laboratory Parameters (Haematology)

Assessment of the safety in terms of haematology parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Treatment-emergent AEs Related to Clinical Laboratory Parameters (Urinalysis)

Assessment of the safety in terms of urinalysis parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Treatment-emergent AEs Related to Clinical Laboratory Parameters (Serum Biochemistry)

Assessment of the safety in terms of serum biochemistry parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase [ALP], Gamma-glutamyl transferase [GGT], bilirubin, creatine kinase, lactate dehydrogenase, urea nitrogen, creatinine, urate, cholesterol, glucose, sodium, potassium, calcium, chloride, phosphate, protein, and albumin) after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

Secondary

Treatment-emergent AEs Related to 12-lead ECG Parameters

Assessment of the safety in terms of the 12-lead ECG parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.

Safety analysis set: All participants who received at least one dose of investigational product.

Posted

Count of Participants

Participants

Screening (Day -21) to Follow-up visit (Days 8-12)

ID	Title	Description
OG000	AB/FF 400/12 BID	Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).

Units	Counts
Participants	OG000

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C542859	aclidinium bromide
D000068759	Formoterol Fumarate
C494814	BID protein, human

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines