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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)

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ClinicalTrials.gov Identifier: NCT01551888
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : November 23, 2016
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: Aclidinium/formoterol 400/12μg
Drug: Formoterol
Enrollment 24
Recruitment Details

The study was conducted in a single center in the United States

First patient visit was in January 2012 and last patient visit was in March 2012

Pre-assignment Details  
Arm/Group Title Sequence 1 Sequence 2
Hide Arm/Group Description Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
Period Title: Period 1
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Period 2
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Overall Study Population
Hide Arm/Group Description All patients participating in the crossover study
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
60.9  (7.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
10
  41.7%
Male
14
  58.3%
1.Primary Outcome
Title Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters
Arm/Group Title Formoterol 12 μg Aclidinium/Formoterol 400/12 μg FDC
Hide Arm/Group Description:
Administered via Foradil® Aerolizer®
Fixed dose combination (FDC) administered via Almirall inhaler
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: pg*hr/mL
87.14  (27.8) 85.15  (28.3)
2.Primary Outcome
Title Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters
Arm/Group Title Formoterol 12 μg Aclidinium/Formoterol 400/12 μg FDC
Hide Arm/Group Description:
Administered via Foradil® Aerolizer®
Fixed dose combination (FDC) administered via Almirall inhaler
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: pg/mL
14.90  (27.9) 16.72  (31.6)
3.Primary Outcome
Title Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters
Arm/Group Title Formoterol 12 μg Aclidinium/Formoterol 400/12 μg FDC
Hide Arm/Group Description:
Administered via Foradil® Aerolizer®
Fixed dose combination (FDC) administered via Almirall inhaler
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: pg/mL
8.23  (39.9) 9.55  (39.0)
4.Secondary Outcome
Title Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters
Arm/Group Title Formoterol 12 μg Aclidinium/Formoterol 400/12 μg FDC
Hide Arm/Group Description:
Administered via Foradil® Aerolizer®
Fixed dose combination (FDC) administered via Almirall inhaler
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: pg*hr/mL
41.63  (32.2) 42.27  (31.3)
Time Frame Up to study Day 17
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aclidinium/Formoterol 400/12 μg Formoterol 12 μg
Hide Arm/Group Description Fixed dose combination (FDC) administered via Almirall inhaler Administered via Foradil® Aerolizer®
All-Cause Mortality
Aclidinium/Formoterol 400/12 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aclidinium/Formoterol 400/12 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   2/24 (8.33%) 
Cardiac disorders     
Aortic valve incompetence  1  0/24 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Lacunar infarction  1  0/24 (0.00%)  1/24 (4.17%) 
Vascular disorders     
Aortic aneurysm  1  0/24 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aclidinium/Formoterol 400/12 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the results by the PI will be subject to mutual agreement between the PI and sponsor.
Results Point of Contact
Name/Title: Study Director
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01551888     History of Changes
Other Study ID Numbers: LAC-PK-01
First Submitted: March 9, 2012
First Posted: March 13, 2012
Results First Submitted: October 4, 2016
Results First Posted: November 23, 2016
Last Update Posted: February 14, 2017