Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT03022097
• Date of registration: 13/01/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients AVANT
• Scientific title: A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
• Date of first enrolment: January 24, 2017
• Target sample size: 1067
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03022097
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

China, India, Philippines, Taiwan, Vietnam

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1. Adult male or non-pregnant, non-lactating female patients aged =40

- 2. Patients with a diagnosis of COPD prior to Visit 1 (screening)

- 3. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1:
post-bronchodilator FEV1 =30% and < 80% and post-bronchodilator FEV1/Forced vital
capacity (FVC) < 70%

- 4. Current or former smokers with a smoking history of = 10 pack-years

- 5. Patients able to perform repeatable pulmonary function testing for FEV1 according
to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005
criteria at Visit 1(screening)

- 6. Patients who understand the study procedures and are willing to participate in the
study as indicated by signing the informed consent

Exclusion Criteria:

- 1. 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.

- 2. Previous enrolment or randomisation in the present study

- 3. History or current diagnosis of asthma

- 4. 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

- 5. 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

- 6. Clinically significant respiratory conditions other than COPD

- 7. Patients who in the Investigator's opinion may need to start a pulmonary
rehabilitation program during the study and/or patients who started/finished it within
3 months prior to screening

- 8. Use of long-term oxygen therapy (=15 hours/day)

- 9. Patient who does not maintain regular day/night, waking/sleeping cycles including
night shift workers

- 10. Clinically significant cardiovascular conditions

- 11. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or
hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated
hypertension

- 12. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/
Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3)
>470 msec as indicated in the centralised reading report assessed at Screening (Visit
1)

- 13. Patients with clinically significant abnormalities in the clinical laboratory
tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1
(screening)

- 14. Patients with abnormal liver function tests defined as Aspartate aminotransferase
(AST), Alanine aminotransferase (ALT), or total bilirubin = 2.5 times upper limit of
normal ranges at screening

- 15. Patient with known non-controlled history of infection with human immunodeficiency
virus and/or active hepatitis

- 16. Patient with a history of hypersensitivity reaction to inhaled anticholinergic
drugs, sympathomimetic amines, inhaled medication or any component thereof

- 17. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction,
acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy

- 18. 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

- 19. Any other serious or uncontrolled physical or mental dysfunction

- 20. Patients with a history (within 2 years prior to Visit 1 (screening) of drug
and/or alcohol abuse that may prevent study compliance based on the Investigator
judgment

- 21. Patients unlikely to be cooperative or cannot comply with the study procedures

- 22. Patients treated with any investigational drug within 30 days (or 6 half-lives,
whichever is longer) prior to screening

- 23. Patients who intended to use any concomitant medication not permitted by this
protocol or who had not undergone the required washout period for a particular
prohibited medication

- 24. Patients unable to give consent, or patients of consenting age but under
guardianship, or vulnerable patients

- 25. Any other conditions that, in the Investigator's opinion, might have indicated the
patient to be unsuitable for the study



Age minimum: 40 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

COPD

Intervention(s)

Drug: Placebo

Drug: Formoterol Fumarate

Drug: Aclidinium bromide

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination

Primary Outcome(s)

Change from baseline in 1-hour morning post-dose dose Forced expiratory volume in 1 second (FEV1) [Time Frame: Week 24]

Change from baseline in trough FEV1 [Time Frame: Week 24]

Change from baseline in morning pre-dose (trough) FEV1 [Time Frame: Week 24]

Secondary Outcome(s)

Change from baseline in peak FEV1 [Time Frame: Week 24]

Change from baseline in St Georges Respiratory Questionnaire (SGRQ) total score [Time Frame: Week 24]

Improvements Transition Dyspnoea Index (TDI) focal score [Time Frame: Week 24]

Secondary ID(s)

D6570C00002

M-AS464-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel