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)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Aclidinium bromide; Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Drug: Formoterol Fumarate; Drug: Placebo

• Registration Number: NCT01572792
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Disposition First Submitted: 2015-02-27
• Disposition First Submitted QC: 2015-02-27
• Disposition First Posted: 2015-03-18
• Results First Submitted: 2016-12-23
• Status Verified: 2017-02
• Results First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 921

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Aclidinium bromide	Aclidinium bromide 400 μg
2	Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)	Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
1	Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)	Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
4	Formoterol Fumarate	Formoterol Fumarate 12 μg
5	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Patients to Experience Any Treatment-emergent Adverse Event	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

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis	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	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)	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

Trial Locations

Locations (208)

Forest Investigative Site 1827; 🇺🇸 Anniston, Alabama, United States

Forest Investigative Site 1920; 🇺🇸 Athens, Alabama, United States

Forest Investigative Site 1162; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1493; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1937; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 1824; 🇺🇸 Gulf Shores, Alabama, United States

Forest Investigative Site 2088; 🇺🇸 Jasper, Alabama, United States

Forest Investigative Site 1918; 🇺🇸 Scottsboro, Alabama, United States

Forest Investigative Site 0909; 🇺🇸 Glendale, Arizona, United States

Forest Investigative Site 1379; 🇺🇸 Phoenix, Arizona, United States

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