Phase 3
N=1,594
AMPLIFY - D6571C00001 Duaklir USA Phase III Study
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT02796677 ↗Enrolled (actual)
1,594
Serious AEs
7.8%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24 — 0.253; 0.169; 0.168; 0.161 Litres — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) (Drug); Aclidinium bromide 400 μg (AB 400 μg) (Drug); Formoterol fumarate 12 μg (FF 12 μg) (Drug); Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg (Other); Tiotropium 18 μg (TIO 18 μg) (Drug); Placebo to TIO 18 μg (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24 |
0.253; 0.169; 0.168; 0.161 | <0.0001 sig |
| PRIMARY Change From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24 |
0.080; 0.066; 0.025; 0.060 | 0.0009 sig |
| PRIMARY Change From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority |
0.064; 0.057 | 0.6377 |
| SECONDARY Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24 |
0.237; 0.162; 0.149; 0.151 | <0.0001 sig |
| SECONDARY Responder (Number of Participants) Analysis of St. George's Respiratory Questionnaire (SGRQ) Total Score With AB/FF 400/12 μg Versus AB 400 μg and FF 12 μg. |
130; 188; 128; 197; 140; 195 | 0.8714 |
Summary
This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion Criteria
- Adult male or non-pregnant, non-lactating female patients aged ≥40.
- Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 470 ms as indicated in the centralised reading report assessed at Screening.
- Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Screening Visit that might comprise patient safety.
- Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis.
- Patient with a history of hypersensitivity reaction to inhaled medication or any component thereof, including paradoxical bronchospasm.
- Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable prostate hypertrophy.
- 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.
- Patients with any other serious or uncontrolled physical or mental dysfunction.
- Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment.
- Patients unlikely to be cooperative or that cannot comply with the study procedures.
- Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening.
- 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.
- Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients. Patients who demonstrate < 80% compliance with the electronic diary during the run-in period.
Data sourced from ClinicalTrials.gov (NCT02796677). 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.