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Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970268
First Posted: September 2, 2009
Last Update Posted: January 6, 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 extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Aclidinium bromide 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 Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks ]
    Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1


Secondary Outcome Measures:
  • Change From Baseline in Peak FEV1 [ Time Frame: 52 weeks ]
    Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).


Enrollment: 291
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Experimental: 2
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

  • Use or anticipated use of any medication prohibited in this study
  • Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
  • The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
  • QTcB of >500 msec on both the pre-dose and post-dose ECG
  • Women who are pregnant, intend to become pregnant, or are breast-feeding
  • A life expectancy of less than 1 year
  • Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
  • Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
  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): NCT00970268


  Show 83 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00970268     History of Changes
Other Study ID Numbers: LAS-MD-36
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: August 14, 2012
Results First Posted: September 14, 2012
Last Update Posted: January 6, 2017
Last Verified: November 2016

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
Anticonvulsants