Phase 2 Completed N=20 Treatment

Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT03276078 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Jul 2019

Primary outcomePrimary: Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose). — 45.82; 3149; 38.82; 4.786 pg/mL

Summary

A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable moderate to severe COPD.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	45.82; 3149; 38.82; 4.786	—
PRIMARY Tmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	0.08; 3.00; 1.75; 1.00	—
PRIMARY Cmin of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	0; 627.7; 0; 0	—
PRIMARY AUC(Last) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	78.61; 20280; 201.1; 20.04	—
PRIMARY AUC(Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).	85.45; 20330; 252.9; 22.78	—
PRIMARY Css,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	60.86; 3691; 81.02; 6.465	—
PRIMARY Css,Min of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	4.528; 1032; 22.88; 1.281	—
PRIMARY Tss,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	0.08; 3.00; 0.50; 0.08	—
PRIMARY λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	0.053; 0.045; 0.048; 0.057	—
PRIMARY t½λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	19.42; 20.95; 17.34; 14.06	—
PRIMARY AUC(ss,Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	168.8; 27300; 540.9; 31.98	—
PRIMARY CL/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).	3140; 422.2	—
PRIMARY Vz/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).	81990; 8284	—
PRIMARY Cav of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	14.07; 2275; 45.07; 2.665	—
PRIMARY %Fluctuation of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	452.5; 117.0; 132.0; 205.9	—
PRIMARY Rac(Cmax) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	1.297; 1.185; 2.070; 1.384	—
PRIMARY Rac[AUC(Tau)] of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	1.966; 1.355; 2.157; 1.436	—
PRIMARY Rac(Cmin) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).	1.877; 1.641; 2.601; 1.822	—
SECONDARY Adverse Events (AEs)/Serious AEs (SAEs)	5; 1	—
SECONDARY Treatment-emergent AEs Related to Blood Pressure	1	—
SECONDARY Treatment-emergent AEs Related to Clinical Laboratory Parameters (Haematology)	—	—
SECONDARY Treatment-emergent AEs Related to Clinical Laboratory Parameters (Urinalysis)	3; 1	—
SECONDARY Treatment-emergent AEs Related to Clinical Laboratory Parameters (Serum Biochemistry)	—	—
SECONDARY Treatment-emergent AEs Related to 12-lead ECG Parameters	—	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03276078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.