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Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01437540
First received: September 19, 2011
Last updated: April 3, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Formoterol Fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to study Week 56 ± 3 days ]
    TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)


Secondary Outcome Measures:
  • Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study [ Time Frame: Up to study Week 52 ]

    <0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts

    >1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride

    Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN


  • Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure [ Time Frame: Up to study Week 56 ± 3 days ]
    Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline

  • Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline [ Time Frame: Up to study Week 56 ± 3 days ]
    Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)


Enrollment: 590
Actual Study Start Date: September 19, 2011
Study Completion Date: April 30, 2013
Primary Completion Date: March 31, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Active Comparator: 2
Inhaled formoterol fumarate 12 μg, twice per day
Drug: Formoterol Fumarate
Inhaled formoterol fumarate 12 μg, twice per day

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Visit 1
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
  • 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 uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
  • Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
  • Current diagnosis of cancer other than basal or squamous cell skin cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437540

  Show 137 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01437540     History of Changes
Other Study ID Numbers: LAC-MD-32
Study First Received: September 19, 2011
Results First Received: December 19, 2016
Last Updated: April 3, 2017

Keywords provided by AstraZeneca:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Formoterol Fumarate
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017