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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:
ClinicalTrials.gov Identifier:
NCT01437540
First Posted: September 21, 2011
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
September 19, 2011
September 21, 2011
December 19, 2016
May 11, 2017
May 11, 2017
September 19, 2011
March 31, 2013   (Final data collection date for primary outcome measure)
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)
  • Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Number of patients to experience a Treatment Emergant Adverse Event (TEAE)
  • Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.
  • Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Number of patients to experience potentially clinically significant changes in ECG from Baseline.
  • Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.
Complete list of historical versions of study NCT01437540 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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)
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Aclidinium Bromide/Formoterol Fumarate
    Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
  • Drug: Formoterol Fumarate
    Inhaled formoterol fumarate 12 μg, twice per day
  • Experimental: 1
    Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
    Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
  • Active Comparator: 2
    Inhaled formoterol fumarate 12 μg, twice per day
    Intervention: Drug: Formoterol Fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
590
April 30, 2013
March 31, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01437540
LAC-MD-32
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Esther Garcia, MD AstraZeneca
AstraZeneca
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP