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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
Secondary ID [1] 0 0
LAC-MD-36
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients to Experience Any Treatment-emergent Adverse Event
Timepoint [1] 0 0
Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
Secondary outcome [1] 0 0
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
Timepoint [1] 0 0
Baseline of lead-in study to end of treatment (up to Week 52)
Secondary outcome [2] 0 0
Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value
Timepoint [2] 0 0
Baseline of lead-in study to end of treatment (up to Week 52)
Secondary outcome [3] 0 0
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
Timepoint [3] 0 0
Baseline of lead-in study to end of treatment (up to Week 52)

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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No specific exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
921
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Forest Investigative Site 1991 - New Lambton
Recruitment hospital [2] 0 0
Forest Investigative Site 1987 - Redcliffe
Recruitment hospital [3] 0 0
Forest Investigative Site 1973 - Woolloongabba
Recruitment hospital [4] 0 0
Forest Investigative Site 2253 - Adelaide
Recruitment hospital [5] 0 0
Forest Investigative Site 1981 - Bedford Park
Recruitment hospital [6] 0 0
Forest Investigative Site 1990 - Daw Park
Recruitment hospital [7] 0 0
Forest Investigative Site 2251 - Toorak Gardens
Recruitment hospital [8] 0 0
Forest Investigative Site 2250 - Clayton
Recruitment hospital [9] 0 0
Forest Investigative Site 1972 - Fitzroy
Recruitment hospital [10] 0 0
Forest Investigative Site 1986 - Geelong
Recruitment hospital [11] 0 0
Forest Investigative Site 1985 - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5041 - Daw Park
Recruitment postcode(s) [7] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Vermont
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
United States of America
State/province [38] 0 0
West Virginia
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
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Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Saskatchewan
Country [44] 0 0
New Zealand
State/province [44] 0 0
Auckland
Country [45] 0 0
New Zealand
State/province [45] 0 0
Christchurch
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New Zealand
State/province [46] 0 0
Dunedin
Country [47] 0 0
New Zealand
State/province [47] 0 0
Hamilton
Country [48] 0 0
New Zealand
State/province [48] 0 0
Tauranga
Country [49] 0 0
New Zealand
State/province [49] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01572792
Trial related presentations / publications
D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16.
Public notes

Contacts
Principal investigator
Name 0 0
Esther Garcia, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01572792