Phase 2
Completed N=24
Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01551888 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Nov 2016
Primary outcomePrimary: Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State — 87.14; 85.15 pg*hr/mL
Summary
The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State |
87.14; 85.15 | — |
| PRIMARY Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State |
14.90; 16.72 | — |
| PRIMARY Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose |
8.23; 9.55 | — |
| SECONDARY Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose |
41.63; 42.27 | — |
Eligibility Criteria
Inclusion Criteria
- Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
- A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.
Exclusion Criteria
- Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Screening
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Screening
- Patients with any clinically significant respiratory conditions other than COPD
- Clinical history that suggests that the patient has asthma as opposed to COPD
- Chronic use of oxygen therapy ≥ 15 hours/day
- Patients with clinically significant cardiovascular conditions
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medications
Data sourced from ClinicalTrials.gov (NCT01551888). 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.