Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium/formoterol 400/12μgDRUG

Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler

FormoterolDRUG

Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Forest Investigative Site 001

Spartanburg, South Carolina, United States

Outcomes

Primary Outcomes

Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State

The standard deviation of the measure is expressed as the coefficient of variation (%)

Time frame: Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)

Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State

The standard deviation of the measure is expressed as the coefficient of variation (%)

Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose

The standard deviation of the measure is expressed as the coefficient of variation (%)

Time frame: Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose

Secondary Outcomes

Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose

The standard deviation of the measure is expressed as the coefficient of variation (%)

Time frame: Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.