This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00970268
First received: September 1, 2009
Last updated: November 16, 2016
Last verified: November 2016
September 1, 2009
November 16, 2016
August 2009
October 2010   (Final data collection date for primary outcome measure)
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
Change from Baseline (Visit 2 of lead-in study LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in morning predose (trough) FEV1 [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00970268 on ClinicalTrials.gov Archive Site
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]).
Change from Baseline (Visit 2 of LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in peak FEV1. [ Time Frame: 52 weeks ]
Not Provided
Not Provided
 
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)
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
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.
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
    Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
  • Drug: Aclidinium bromide
    Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
  • Experimental: 1
    Aclidinium bromide dose, inhaled, for 52 weeks of treatment
    Intervention: Drug: Aclidinium bromide
  • Experimental: 2
    Aclidinium bromide dose, inhaled, for 52 weeks of treatment
    Intervention: Drug: Aclidinium bromide
D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00970268
LAS-MD-36
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Esther Garcia, MD AstraZeneca
AstraZeneca
November 2016

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