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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01572792
Registration number
NCT01572792
Ethics application status
Date submitted
4/04/2012
Date registered
6/04/2012
Date last updated
21/04/2017
Titles & IDs
Public title
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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Scientific 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)
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Secondary ID [1]
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LAC-MD-36
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Treatment: Drugs - Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Treatment: Drugs - Aclidinium bromide
Treatment: Drugs - Formoterol Fumarate
Treatment: Drugs - Placebo
Experimental: 1 - Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Experimental: 2 - Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Active Comparator: 3 - Aclidinium bromide 400 µg
Active Comparator: 4 - Formoterol Fumarate 12 µg
Placebo Comparator: 5 - Placebo
Treatment: Drugs: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
Treatment: Drugs: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Treatment: Drugs: Aclidinium bromide
Inhaled Aclidinium bromide 400 µg, twice per day
Treatment: Drugs: Formoterol Fumarate
Inhaled Formoterol Fumarate 12 µg, twice per day
Treatment: Drugs: Placebo
Inhaled dose-matched placebo, twice per day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Patients to Experience Any Treatment-emergent Adverse Event
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Assessment method [1]
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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
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Timepoint [1]
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Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
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Secondary outcome [1]
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Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
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Assessment method [1]
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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
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Timepoint [1]
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Baseline of lead-in study to end of treatment (up to Week 52)
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Secondary outcome [2]
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Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value
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Assessment method [2]
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Timepoint [2]
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Baseline of lead-in study to end of treatment (up to Week 52)
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Secondary outcome [3]
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Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
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Assessment method [3]
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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
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Timepoint [3]
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Baseline of lead-in study to end of treatment (up to Week 52)
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Eligibility
Key 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.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- No specific exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2013
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Sample size
Target
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Accrual to date
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Final
921
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Forest Investigative Site 1991 - New Lambton
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Recruitment hospital [2]
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Forest Investigative Site 1987 - Redcliffe
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Recruitment hospital [3]
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Forest Investigative Site 1973 - Woolloongabba
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Forest Investigative Site 2253 - Adelaide
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Forest Investigative Site 1981 - Bedford Park
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Forest Investigative Site 1990 - Daw Park
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Forest Investigative Site 2251 - Toorak Gardens
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Forest Investigative Site 2250 - Clayton
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Forest Investigative Site 1972 - Fitzroy
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Forest Investigative Site 1986 - Geelong
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Recruitment hospital [11]
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Forest Investigative Site 1985 - Parkville
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Recruitment postcode(s) [2]
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4020 - Redcliffe
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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5041 - Daw Park
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Recruitment postcode(s) [7]
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5065 - Toorak Gardens
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Recruitment postcode(s) [10]
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3220 - Geelong
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment outside Australia
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Alabama
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01572792
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Esther Garcia, MD
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01572792
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