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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aclidinium/formoterol 400/12μg

Formoterol

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Forest Investigative Site 001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aclidinium/formoterol 400/12μg FDC

Formoterol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 (%)

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 (%)

Secondary Outcome Measures

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 (%)

Full Information

NCT ID

NCT01551888

First Posted

March 9, 2012

Last Updated

December 22, 2016

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01551888

Brief Title

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

Official Title

A Phase 2a, Randomized, Open-Label, 2-Way Crossover Study To Determine The Pharmacokinetics, Safety, And Tolerability Of Aclidinium/Formoterol 400/12 µg Fixed Dose Combination Via Almirall Inhaler And Formoterol 12 µg Via Foradil® Aerolizer® In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aclidinium/formoterol 400/12μg FDC

Arm Type

Experimental

Arm Description

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

Arm Title

Formoterol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aclidinium/formoterol 400/12μg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Formoterol

Other Intervention Name(s)

Foradil® Aerolizer®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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)

Title

Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State

Description

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

Time Frame

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Esther Garcia, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Forest Investigative Site 001

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4102&filename=LAC-PK-01_CSRredacted.pdf

Description

CSR Synopsis

Learn more about this trial

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

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