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)
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| ClinicalTrials.gov Identifier: NCT01572792 |
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Recruitment Status :
Completed
First Posted : April 6, 2012
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
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| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 921 participants |
| 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) |
| Study Start Date : | April 2012 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
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Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day |
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Experimental: 2
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
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Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day |
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Active Comparator: 3
Aclidinium bromide 400 μg
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Drug: Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day |
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Active Comparator: 4
Formoterol Fumarate 12 μg
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Drug: Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day |
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Placebo Comparator: 5
Placebo
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Drug: Placebo
Inhaled dose-matched placebo, twice per day |
- 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
- 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
- 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).
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Esther Garcia, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01572792 |
| Other Study ID Numbers: |
LAC-MD-36 |
| First Posted: | April 6, 2012 Key Record Dates |
| Results First Posted: | April 21, 2017 |
| Last Update Posted: | April 21, 2017 |
| Last Verified: | February 2017 |
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COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema |
Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Bromides Formoterol Fumarate 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 |