Phase 3
N=1,066
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
COPD
Bottom Line
View on ClinicalTrials.gov: NCT03022097 ↗Enrolled (actual)
1,066
Serious AEs
8.2%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1) — 0.248; 0.156; 0.138; -0.050 Litres — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aclidinium bromide/formoterol Fixed-Dose Combination (Drug); Aclidinium bromide (Drug); Formoterol Fumarate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1) |
0.248; 0.156; 0.138; -0.050 | <0.001 sig |
| PRIMARY Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate |
0.081; 0.050; -0.004; -0.084 | <0.001 sig |
| PRIMARY Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide |
0.081; 0.050; -0.004; -0.084 | <0.001 sig |
| SECONDARY Change From Baseline in Peak FEV1 |
0.324; 0.225; 0.191; 0.008 | <0.001 sig |
| SECONDARY Improvements Transition Dyspnoea Index (TDI) Focal Score |
2.9; 2.6; 2.4; 2.1 | 0.005 sig |
| SECONDARY Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score |
-8.7; -7.6; -7.2; -4.7 | 0.003 sig |
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).
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03022097). 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.