Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
AVANT
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.
2 other identifiers
interventional
1,625
5 countries
74
Brief Summary
This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine 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 (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
Longer than P75 for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedStudy Start
First participant enrolled
February 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2022
CompletedResults Posted
Study results publicly available
March 26, 2025
CompletedMarch 26, 2025
March 1, 2025
5.2 years
January 13, 2017
March 7, 2023
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Week 24, 1-hour morning post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Week 24, morning pre-dose (trough)
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Week 24, morning pre-dose (trough)
Secondary Outcomes (3)
Change From Baseline in Peak FEV1
Week 24, peak
Improvements Transition Dyspnoea Index (TDI) Focal Score
Week 24
Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score
Week 24
Study Arms (4)
Experimental 1
EXPERIMENTALAclidinium bromide 400μg/Formoterol fumarate 12 μg
Experimental 2
EXPERIMENTALAclidinium bromide 400 μg
Comparator
ACTIVE COMPARATORFormoterol fumarate 12 μg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Eligibility Criteria
You may qualify if:
- \. Adult male or non-pregnant, non-lactating female patients aged ≥40
- \. Patients with a diagnosis of COPD prior to Visit 1 (screening)
- \. 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%
- \. Current or former smokers with a smoking history of ≥ 10 pack-years
- \. 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)
- \. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent
You may not qualify if:
- \. 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
- \. Clinically significant respiratory conditions other than COPD
- \. 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
- \. Use of long-term oxygen therapy (≥15 hours/day)
- \. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
- \. Clinically significant cardiovascular conditions
- \. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- \. 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)
- \. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening)
- \. 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
- \. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (74)
Research Site
Baotou, 14010, China
Research Site
Beijing, 100050, China
Research Site
Beijing, 100097, China
Research Site
Beijing, 102300, China
Research Site
Beijing, CN-100083, China
Research Site
Cangzhou, 61000, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410005, China
Research Site
Changsha, 430033, China
Research Site
Chengdu, 610072, China
Research Site
Guangzhou, 510530, China
Research Site
Haikou, 570311, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310005, China
Research Site
Hangzhou, 310014, China
Research Site
Hefei, 230001, China
Research Site
Hefei, 230022, China
Research Site
Hefei, 230061, China
Research Site
Hengyang, 50012, China
Research Site
Hohhot, 010017, China
Research Site
Liangyugang, 222002, China
Research Site
Linhai, 317000, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 210009, China
Research Site
Qiqihar, 161005, China
Research Site
Shanghai, 200030, China
Research Site
Shanghai, 200040, China
Research Site
Shanghai, 200062, China
Research Site
Shanghai, 200090, China
Research Site
Shanghai, 200240, China
Research Site
Shanghai, 200433, China
Research Site
Shanghai, 201200, China
Research Site
Shanxi, 30001, China
Research Site
Shengyang, 110004, China
Research Site
Shenzhen, 518020, China
Research Site
Shenzhen, 518053, China
Research Site
Shijiazhuang, 050000, China
Research Site
Taiyuan, 030001, China
Research Site
Tianjin, 300050, China
Research Site
Wenzhou, 325015, China
Research Site
Wuxi, 214023, China
Research Site
Xi'an, 710061, China
Research Site
Xiamen, 361004, China
Research Site
Xining, 810007, China
Research Site
Yangzhou, 225000, China
Research Site
Yanji, 133000, China
Research Site
Yinchuan, 750004, China
Research Site
Zhanjiang, 524001, China
Research Site
Ahmedabad, 380060, India
Research Site
Alappuzha, 688524, India
Research Site
Ernākulam, 683577, India
Research Site
Guntur, 522001, India
Research Site
Jaipur, 302006, India
Research Site
Kozhikode, 673008, India
Research Site
Mysore, 57002, India
Research Site
Nagpur, 440010, India
Research Site
Nagpur, 440012, India
Research Site
Nagpur, 440019, India
Research Site
Pune, 411019, India
Research Site
Pune, 411057, India
Research Site
Pune, 440012, India
Research Site
Vijayawada, 520 008, India
Research Site
Caloocan, 1400, Philippines
Research Site
Iloilo City, 5000, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Quezon City, 1000, Philippines
Research Site
Quezon City, 1100, Philippines
Research Site
Quezon City, 1101, Philippines
Research Site
Keelung, 20448, Taiwan
Research Site
Taichung, 40201, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Hanoi, 10000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2017
First Posted
January 16, 2017
Study Start
February 2, 2017
Primary Completion
April 14, 2022
Study Completion
April 14, 2022
Last Updated
March 26, 2025
Results First Posted
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.