Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38) (LAS-MD-38)
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| ClinicalTrials.gov Identifier: NCT01045161 |
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Recruitment Status :
Completed
First Posted : January 8, 2010
Results First Posted : December 9, 2015
Last Update Posted : January 23, 2017
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Drug: Aclidinium bromide Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 544 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | June 2011 |
| Actual Study Completion Date : | June 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
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Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment. |
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Experimental: 2
Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
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Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment. |
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Placebo Comparator: 3
Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
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Drug: Placebo
Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment |
Primary Outcome Measures :
- Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Week 0) to Week 12 ]Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
- Part B: Morning Predose (Trough) FEV1 [ Time Frame: Change from baseline (Week 0) to 52 Weeks ]Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
Secondary Outcome Measures :
- Part A: Peak Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Week 0) to Week 12 ]Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)
- Part B: Peak FEV1 [ Time Frame: Change from baseline (Week 0) to 52 Weeks ]Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
- Current or former cigarette smokers
Exclusion Criteria:
- Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
- Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
- Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
- History or presence of asthma verified from medical records
- Chronic use of oxygen therapy greater than or equal to 15 hours per day
- Patient with uncontrolled infection due to HIV and/or active hepatitis
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics
- Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
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): NCT01045161
Locations
Show 112 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Esther Garcia, Ph. D. | AstraZeneca |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01045161 |
| Other Study ID Numbers: |
LAS-MD-38 |
| First Posted: | January 8, 2010 Key Record Dates |
| Results First Posted: | December 9, 2015 |
| Last Update Posted: | January 23, 2017 |
| Last Verified: | November 2016 |
Keywords provided by AstraZeneca:
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Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema |
Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Respiratory Tract Diseases Bromides Anticonvulsants |