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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)

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ClinicalTrials.gov Identifier: NCT00970268
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : September 14, 2012
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Intervention Drug: Aclidinium bromide
Enrollment 291
Recruitment Details Patient recruitment occurred from August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.
Pre-assignment Details From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent To Treat (ITT) Population.
Arm/Group Title Aclidinium Bromide 200 μg Aclidinium Bromide 400 μg
Hide Arm/Group Description Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Period Title: Overall Study
Started 139 152
Completed 96 103
Not Completed 43 49
Reason Not Completed
Withdrawal by Subject             12             19
Adverse Event             15             12
Lack of Efficacy             3             6
Protocol Violation             4             7
Other Reason             3             1
COPD Exacerbation             4             2
Lost to Follow-up             1             2
Inclusion/Exclusion Criteria             1             0
Arm/Group Title Aclidinium Bromide 200 μg Aclidinium Bromide 400 μg Total
Hide Arm/Group Description Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. Total of all reporting groups
Overall Number of Baseline Participants 137 152 289
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 152 participants 289 participants
63.3  (10.1) 64.4  (10.0) 63.9  (9.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 152 participants 289 participants
≥ 40 to < 60 years 49 40 89
≥ 60 to < 70 years 51 67 118
≥ 70 years 37 45 82
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 152 participants 289 participants
Female
63
  46.0%
76
  50.0%
139
  48.1%
Male
74
  54.0%
76
  50.0%
150
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 152 participants 289 participants
United States 128 138 266
Canada 9 14 23
1.Primary Outcome
Title Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Hide Description 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
Time Frame Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population
Arm/Group Title Placebo - Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg Placebo - Aclidinium Bromide 400 μg Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg
Hide Arm/Group Description:
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
Overall Number of Participants Analyzed 38 76 41 91
Least Squares Mean (Standard Error)
Unit of Measure: L
-0.035  (0.040) 0.069  (0.028) 0.069  (0.037) 0.056  (0.025)
2.Secondary Outcome
Title Change From Baseline in Peak FEV1
Hide Description 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]).
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo - Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg Placebo - Aclidinium Bromide 400 μg Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg
Hide Arm/Group Description:
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
Overall Number of Participants Analyzed 38 76 41 91
Least Squares Mean (Standard Error)
Unit of Measure: L
0.111  (0.040) 0.213  (0.028) 0.222  (0.038) 0.219  (0.025)
Time Frame Adverse Event Reporting occurred from August 2009 to November 2010 at 77 study sites (71 in the United States and 6 additional sites in Canada).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo to Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg Placebo to Aclidinium Bromide 400μg Aclidinium Bromide 400μg to Aclidinium Bromide 400μg
Hide Arm/Group Description Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment. Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
All-Cause Mortality
Placebo to Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg Placebo to Aclidinium Bromide 400μg Aclidinium Bromide 400μg to Aclidinium Bromide 400μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo to Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg Placebo to Aclidinium Bromide 400μg Aclidinium Bromide 400μg to Aclidinium Bromide 400μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/44 (15.91%)   13/93 (13.98%)   7/46 (15.22%)   13/106 (12.26%) 
Cardiac disorders         
Acute myocardial infarction  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Angina pectoris  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Atrial flutter  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Cardiogenic shock  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Coronary artery disease  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Ventricular fibrillation  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Acute coronary syndrome  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Angina unstable  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Gastrointestinal disorders         
Colitis  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Oesophagitis  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Constipation  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Haemorrhoidal haemorrhage  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Small intestinal obstruction  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
General disorders         
Non-cardiac chest pain  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Infections and infestations         
Pneumonia  1  1/44 (2.27%)  3/93 (3.23%)  0/46 (0.00%)  2/106 (1.89%) 
Influenza  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Lower respiratory tract infection  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Pneumonia bacterial  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Staphylococcal infection  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Gastroenteritis  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Lobar pneumonia  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Postoperative wound infection  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Injury, poisoning and procedural complications         
Humerus fracture  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Spinal compression fracture  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Contusion  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Dyspepsia  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Femoral neck fracture  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Multiple drug overdose accidental  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Thermal burn  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Upper limb fracture  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Hypovolaemia  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Neck pain  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Breast cancer stage II  1  0/44 (0.00%)  0/93 (0.00%)  1/46 (2.17%)  0/106 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Small cell lung cancer stage unspecified  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Nervous system disorders         
Haemorrhagic stroke  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Carotid artery stenosis  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Syncope  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  2/44 (4.55%)  3/93 (3.23%)  1/46 (2.17%)  6/106 (5.66%) 
Respiratory failure  1  0/44 (0.00%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Acute respiratory failure  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Pulmonary oedema  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  0/106 (0.00%) 
Vascular disorders         
Hypertension  1  1/44 (2.27%)  0/93 (0.00%)  0/46 (0.00%)  1/106 (0.94%) 
Haematoma  1  0/44 (0.00%)  1/93 (1.08%)  0/46 (0.00%)  0/106 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo to Aclidinium Bromide 200 μg Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg Placebo to Aclidinium Bromide 400μg Aclidinium Bromide 400μg to Aclidinium Bromide 400μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/44 (81.82%)   63/93 (67.74%)   28/46 (60.87%)   64/106 (60.38%) 
Cardiac disorders         
Bundle branch block left  1  3/44 (6.82%)  3/93 (3.23%)  0/46 (0.00%)  3/106 (2.83%) 
Gastrointestinal disorders         
Gastrooesophageal reflux disease  1  3/44 (6.82%)  0/93 (0.00%)  1/46 (2.17%)  2/106 (1.89%) 
Nausea  1  4/44 (9.09%)  1/93 (1.08%)  1/46 (2.17%)  2/106 (1.89%) 
General disorders         
Fatigue  1  4/44 (9.09%)  3/93 (3.23%)  0/46 (0.00%)  3/106 (2.83%) 
Pyrexia  1  3/44 (6.82%)  0/93 (0.00%)  0/46 (0.00%)  3/106 (2.83%) 
Infections and infestations         
Nasopharyngitis  1  4/44 (9.09%)  8/93 (8.60%)  4/46 (8.70%)  10/106 (9.43%) 
Urinary tract infection  1  4/44 (9.09%)  4/93 (4.30%)  3/46 (6.52%)  8/106 (7.55%) 
Upper respiratory tract infection  1  5/44 (11.36%)  6/93 (6.45%)  2/46 (4.35%)  6/106 (5.66%) 
Bronchitis  1  3/44 (6.82%)  1/93 (1.08%)  1/46 (2.17%)  4/106 (3.77%) 
Sinusitis  1  5/44 (11.36%)  6/93 (6.45%)  1/46 (2.17%)  3/106 (2.83%) 
Pneumonia  1  3/44 (6.82%)  4/93 (4.30%)  1/46 (2.17%)  2/106 (1.89%) 
Injury, poisoning and procedural complications         
Fall  1  0/44 (0.00%)  6/93 (6.45%)  3/46 (6.52%)  2/106 (1.89%) 
Contusion  1  0/44 (0.00%)  6/93 (6.45%)  5/46 (10.87%)  1/106 (0.94%) 
Investigations         
Blood glucose increased  1  3/44 (6.82%)  3/93 (3.23%)  3/46 (6.52%)  0/106 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/44 (4.55%)  7/93 (7.53%)  0/46 (0.00%)  5/106 (4.72%) 
Arthralgia  1  2/44 (4.55%)  5/93 (5.38%)  3/46 (6.52%)  4/106 (3.77%) 
Nervous system disorders         
Headache  1  3/44 (6.82%)  5/93 (5.38%)  2/46 (4.35%)  4/106 (3.77%) 
Psychiatric disorders         
Insomnia  1  2/44 (4.55%)  2/93 (2.15%)  2/46 (4.35%)  6/106 (5.66%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disorder  1  16/44 (36.36%)  23/93 (24.73%)  14/46 (30.43%)  24/106 (22.64%) 
Oropharyngeal pain  1  2/44 (4.55%)  2/93 (2.15%)  0/46 (0.00%)  6/106 (5.66%) 
Cough  1  2/44 (4.55%)  7/93 (7.53%)  4/46 (8.70%)  4/106 (3.77%) 
Dyspnoea  1  1/44 (2.27%)  7/93 (7.53%)  4/46 (8.70%)  4/106 (3.77%) 
Skin and subcutaneous tissue disorders         
Rash  1  1/44 (2.27%)  2/93 (2.15%)  1/46 (2.17%)  6/106 (5.66%) 
Vascular disorders         
Hypertension  1  3/44 (6.82%)  4/93 (4.30%)  1/46 (2.17%)  3/106 (2.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact
Name/Title: AstraZeneca Clinical
Organization: Study Information Center
Phone: 1-877-240-9479
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