Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
NCT ID: NCT03022097
Last Updated: 2025-03-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1625 participants
INTERVENTIONAL
2017-02-02
2022-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01437397
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT01572792
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
NCT03276078
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00706914
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01908140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental 1
Aclidinium bromide 400μg/Formoterol fumarate 12 μg
Aclidinium bromide/formoterol Fixed-Dose Combination
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Experimental 2
Aclidinium bromide 400 μg
Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Comparator
Formoterol fumarate 12 μg
Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
Placebo
Placebo
Placebo
Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aclidinium bromide/formoterol Fixed-Dose Combination
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
Placebo
Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Cangzhou, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Guangzhou, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Hengyang, , China
Research Site
Hohhot, , China
Research Site
Liangyugang, , China
Research Site
Linhai, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Qiqihar, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanxi, , China
Research Site
Shengyang, , China
Research Site
Shenzhen, , China
Research Site
Shenzhen, , China
Research Site
Shijiazhuang, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Wenzhou, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Xining, , China
Research Site
Yangzhou, , China
Research Site
Yanji, , China
Research Site
Yinchuan, , China
Research Site
Zhanjiang, , China
Research Site
Ahmedabad, , India
Research Site
Alappuzha, , India
Research Site
Ernākulam, , India
Research Site
Guntur, , India
Research Site
Jaipur, , India
Research Site
Kozhikode, , India
Research Site
Mysore, , India
Research Site
Nagpur, , India
Research Site
Nagpur, , India
Research Site
Nagpur, , India
Research Site
Pune, , India
Research Site
Pune, , India
Research Site
Pune, , India
Research Site
Vijayawada, , India
Research Site
Caloocan City, , Philippines
Research Site
Iloilo City, , Philippines
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Keelung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M-AS464-30
Identifier Type: OTHER
Identifier Source: secondary_id
D6570C00002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.