Phase 2
Completed N=132
Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)
Source: ClinicalTrials.gov NCT02796651 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Feb 2018
Primary outcomePrimary: Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment — 0.108; 0.117; 0.161; 0.122 Litre/Hour — p=<0.001
Summary
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment |
0.108; 0.117; 0.161; 0.122; 0.000 | <0.001 sig |
| SECONDARY Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment |
0.111; 0.148; 0.205; 0.195; 0.246; -0.019 | <0.001 sig |
| SECONDARY Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment |
0.166; 0.177; 0.225; 0.186; 0.007 | <0.001 sig |
| SECONDARY Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment |
0.077; 0.067; 0.102; 0.061; 0.002 | 0.027 sig |
Eligibility Criteria
Inclusion Criteria
- Adult male or non-pregnant, non-lactating female patients aged ≥40.
- Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1.
- Patients with moderate to severe stable COPD: post-bronchodilator FEV1 ≥ 30% and 470 ms as indicated in the centralized reading report assessed at Visit 1.
- Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Visit 1 that might compromise patient safety.
- Patients with a history of hypersensitivity reaction to an inhaled medication or any component thereof, including paradoxical bronchospasm.
- Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic unstable 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 who cannot comply with the study procedures.
- Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1.
- 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.
- Any other conditions that, in the investigator's opinion, might render the patient to be unsuitable for the study.
- 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 randomization in the present study D6571C00002.
Data sourced from ClinicalTrials.gov (NCT02796651). 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. Informational only — not medical advice.