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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
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Drug: Aclidinium bromide Drug: Formoterol Fumarate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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



Other Outcome Measures:
  • 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).


Enrollment: 921
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
Experimental: 2
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Active Comparator: 3
Aclidinium bromide 400 μg
Drug: Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day
Active Comparator: 4
Formoterol Fumarate 12 μg
Drug: Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day
Placebo Comparator: 5
Placebo
Drug: Placebo
Inhaled dose-matched placebo, twice per day

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572792


  Show 208 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01572792     History of Changes
Other Study ID Numbers: LAC-MD-36
First Submitted: April 4, 2012
First Posted: April 6, 2012
Results First Submitted: December 23, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: February 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
Formoterol Fumarate
Bromides
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
Anticonvulsants