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Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572792
First Posted: April 6, 2012
Last Update Posted: April 21, 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
April 4, 2012
April 6, 2012
December 23, 2016
April 21, 2017
April 21, 2017
April 2012
June 2013   (Final data collection date for primary outcome measure)
Percentage of Patients to Experience Any Treatment-emergent Adverse Event [ Time Frame: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52) ]
For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
Safety and tolerability [ Time Frame: 28 weeks ]
Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters
Complete list of historical versions of study NCT01572792 on ClinicalTrials.gov Archive Site
  • Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]

    Potentially clinically significant change:

    >1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN

    The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

  • Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]
  • Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight) [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]

    Potentially clinically significant change:

    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 Weight increase or decrease ≥7% from baseline

    The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

Not Provided
  • Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]
  • Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]
  • Transition Dyspnea Index (TDI) Focal Score at End of Study [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]
    The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.
  • Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]
    St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).
Not Provided
 
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
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 Fixed-Dose Combination (FDC)
    Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
  • Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
    Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
  • Drug: Aclidinium bromide
    Inhaled Aclidinium bromide 400 μg, twice per day
  • Drug: Formoterol Fumarate
    Inhaled Formoterol Fumarate 12 μg, twice per day
  • Drug: Placebo
    Inhaled dose-matched placebo, twice per day
  • Experimental: 1
    Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
    Intervention: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
  • Experimental: 2
    Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
    Intervention: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
  • Active Comparator: 3
    Aclidinium bromide 400 μg
    Intervention: Drug: Aclidinium bromide
  • Active Comparator: 4
    Formoterol Fumarate 12 μg
    Intervention: Drug: Formoterol Fumarate
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
921
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of the treatment phase of the lead-in study, LAC-MD-31
  • Written informed consent obtained from the patient before the initiation of any study specific procedures
  • No medical contraindication as judged by the PI
  • Compliance with LAC-MD-31 study procedures and IP dosing.

Exclusion Criteria:

  • No specific exclusion criteria
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   New Zealand,   United States
 
 
NCT01572792
LAC-MD-36
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Esther Garcia, MD AstraZeneca
AstraZeneca
February 2017

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