Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
1 other identifier
interventional
1,692
4 countries
222
Brief Summary
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Sep 2011
222 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
March 23, 2017
CompletedMarch 23, 2017
January 1, 2017
1.4 years
September 19, 2011
November 16, 2016
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
Week 24 of treatment
Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)
Week 24 of treatment
Secondary Outcomes (2)
Change in Transition Dyspnea Index (TDI) Focal Score
Week 24 of treatment
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Week 24 of treatment
Study Arms (5)
1
EXPERIMENTALAclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg
2
EXPERIMENTALAclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg
3
ACTIVE COMPARATORAclidinium monotherapy 400 μg
4
ACTIVE COMPARATORFormoterol monotherapy 12 μg
5
PLACEBO COMPARATORPlacebo
Interventions
Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day
Eligibility Criteria
You may qualify if:
- Male or female patients at least 40 years of age
- Current or former cigarette smoker with a cigarette smoking history of at least 10 pack-years
- A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the GOLD guidelines and stable airway obstruction. Patients had to have a postbronchodilator FEV1/FVC ratio \< 70% at Visit 1 (GOLD, 2010)
- Post-albuterol/salbutamol FEV1 values ≥ 30% and \< 80% of predicted value. FEV1 was measured at the Screening Visit (Visit 1) 10 to 15 minutes after inhalation of albuterol/salbutamol. Predicted normal used for calculation purposes were based on National Health and Nutrition Examination Survey III predicted values (Hankinson et al, 1999)
- Able to perform acceptable and repeatable pulmonary function testing for FEV1 according to ATS/ERS criteria (Miller et al, 2005) at Screening Visit (Visit 1) and throughout their participation in the trial
- Negative serum β-human chorionic gonadotropin pregnancy test at Visit 1 and must have been using hormonal contraceptives or a barrier method plus a spermicidal agent; otherwise at least 1-year postmenopausal or surgically sterile, defined as having a hysterectomy or tubal ligation (applied to female patients only)
- Judged by the Principal Investigator to be in otherwise good stable health based on medical history, physical examination, ECGs, and routine laboratory data evaluations
- Patients previously randomized in an aclidinium monotherapy trial were permitted as long as it had been at least 6 months since the completion of their previous trial participation
- Able to understand the study procedures and be willing to participate in the study as indicated by signing the informed consent
You may not qualify if:
- Hospitalization for an acute COPD exacerbation within 3 months before Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. Patients who developed a respiratory tract infection or COPD exacerbation during the washout or run-in period were discontinued from the study before randomization
- Any clinically significant respiratory conditions other than COPD, including active tuberculosis, history of interstitial lung disease, pulmonary thromboembolic disease, history of α1-antitrypsin deficiency, pulmonary resection, lung volume surgery, or any other thoracic surgery during the past 12 months, history of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener syndrome), post organ transplantation, or expected to require thoracotomy or other lung surgery during the study
- Clinical history suggesting that the patient had asthma as opposed to COPD (Study Physician was to be contacted to discuss eligibility, if necessary)
- Chronic use of oxygen therapy ≥ 15 hours/day
- Body mass index(BMI) ≥ 40 kg/m2
- Patients who intended to start a pulmonary rehabilitation program during the trial were excluded, as well as those who finished or started it within 3 months prior to Screening Visit
- Clinically significant cardiovascular conditions including: myocardial infarction within 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 within the previous 6 months; the presence of an automated implantable cardioverter-defibrillator; history of thoracic surgery within the past year before screening; hospitalization within the previous 12 months for heart failure of New York Heart Association functional class III (marked limitation of physical activity and only comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea), or class IV (unable to carry out any physical activity without discomfort) (Criteria Committee of the New York Heart Association criteria, 1994)
- Any uncontrolled infection that may have placed the patient at risk resulting from human immunodeficiency virus, active hepatitis and/or patients with diagnosed active tuberculosis
- QTcB \> 470 msec in the resting ECGs performed at Screening (Visit 1), as indicated in the centralized ECG vendor generated report. Patients who were on a stable dose of medication that may prolong the QTc, but had a documented, stable, and normal QTc, could have been considered
- QTcB \> 470 msec in the resting ECGs performed before randomization at Visit 2, as indicated in the paper tracing generated by the Sponsor-provided ECG equipment
- Clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination or vital signs at Visit 1 except for those related to COPD
- History of drug or alcohol abuse within the previous 5 years
- Any other serious or uncontrolled physical or mental condition/disease that, as judged by the Investigator, could have placed the patient at higher risk derived from his/her participation in the study, could have confounded the results of the study, or would be likely to have prevented the patient from complying with the requirements of the study or completing the study. If there was a history of such disease, but the condition had been stable for more than 1 year and was judged by the Investigator not to interfere with the patient's participation in the study, the patient may have been included, with the documented approval of the Study Physician
- History of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) or a history of acute urinary retention, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or narrow-angle glaucoma. (Note: Patients who had well controlled, stable, asymptomatic benign prostatic hyperplasia were not to be excluded)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (222)
Forest Investigative Site 1827
Anniston, Alabama, 36207, United States
Forest Investigative Site 1920
Athens, Alabama, 35611, United States
Forest Investigative Site 1162
Birmingham, Alabama, 35209, United States
Forest Investigative Site 1493
Birmingham, Alabama, 35209, United States
Forest Investigative Site 1937
Birmingham, Alabama, 35216, United States
Forest Investigative Site 1893
Florence, Alabama, 35630, United States
Forest Investigative Site 1824
Gulf Shores, Alabama, 36542, United States
Forest Investigative Site 2088
Jasper, Alabama, 35501, United States
Forest Investigative Site 1918
Scottsboro, Alabama, 35768, United States
Forest Investigative Site 0909
Glendale, Arizona, 85306, United States
Forest Investigative Site 1958
Mesa, Arizona, 85206, United States
Forest Investigative Site 1379
Phoenix, Arizona, 85018, United States
Forest Investigative Site 1822
Anaheim, California, 92801, United States
Forest Investigative Site 1483
Buena Park, California, 90620, United States
Forest Investigative Site 1809
Fountain Valley, California, 92708, United States
Forest Investigative Site 1156
Fresno, California, 93726, United States
Forest Investigative Site 1871
Lincoln, California, 95648, United States
Forest Investigative Site 1873
Los Angeles, California, 90073, United States
Forest Investigative Site 2064
Riverside, California, 92506, United States
Forest Investigative Site 1427
Sacramento, California, 95817, United States
Forest Investigative Site 1866
Sacramento, California, 95842, United States
Forest Investigative Site 1125
San Diego, California, 92103, United States
Forest Investigative Site 1898
San Diego, California, 92111, United States
Forest Investigative Site 2009
San Diego, California, 92120, United States
Forest Investigative Site 1374
Torrance, California, 90505, United States
Forest Investigative Site 1813
Tustin, California, 92780, United States
Forest Investigative Site 1883
Vista, California, 92083, United States
Forest Investigative Site 1380
Golden, Colorado, 80401, United States
Forest Investigative Site 1137
Pueblo, Colorado, 81001, United States
Forest Investigative Site 1327
Wheat Ridge, Colorado, 80033, United States
Forest Investigative Site 1976
Waterbury, Connecticut, 06708, United States
Forest Investigative Site 1821
Bay Pines, Florida, 33744, United States
Forest Investigative Site 1154
Brandon, Florida, 33511, United States
Forest Investigative Site 1944
Brandon, Florida, 33511, United States
Forest Investigative Site 1364
Clearwater, Florida, 33756, United States
Forest Investigative Site 1152
Clearwater, Florida, 33765, United States
Forest Investigative Site 1875
Clearwater, Florida, 33765, United States
Forest Investigative Site 0670
DeLand, Florida, 32720, United States
Forest Investigative Site 1516
Edgewater, Florida, 32132, United States
Forest Investigative Site 0990
Fort Lauderdale, Florida, 33316, United States
Forest Investigative Site 1513
Hialeah, Florida, 33012, United States
Forest Investigative Site 1854
Hialeah, Florida, 33012, United States
Forest Investigative Site 1882
Hollywood, Florida, 33024, United States
Forest Investigative Site 1543
Jacksonville, Florida, 32216, United States
Forest Investigative Site 1416
Kissimmee, Florida, 34741, United States
Forest Investigative Site 1167
Melbourne, Florida, 32935, United States
Forest Investigative Site 1868
Miami, Florida, 33135, United States
Forest Investigative Site 1432
Miami, Florida, 33143, United States
Forest Investigative Site 1979
Miami, Florida, 33144, United States
Forest Investigative Site 1819
Naples, Florida, 34119, United States
Forest Investigative Site 1808
North Miami Beach, Florida, 33179, United States
Forest Investigative Site 1950
Oldsmar, Florida, 34677, United States
Forest Investigative Site 1145
Ormond Beach, Florida, 32174, United States
Forest Investigative Site 1094
Panama City, Florida, 32405, United States
Forest Investigative Site 1803
Pembroke Pines, Florida, 33028, United States
Forest Investigative Site 974
Pensacola, Florida, 32504, United States
Forest Investigative Site 1829
Saint Cloud, Florida, 34769, United States
Forest Investigative Site 1817
Sarasota, Florida, 34233, United States
Forest Investigative Site 1876
St. Petersburg, Florida, 33701, United States
Forest Investigative Site 1874
St. Petersburg, Florida, 33704, United States
Forest Investigative Site 2082
Tamarac, Florida, 33321, United States
Forest Investigative Site 2053
Tampa, Florida, 33603, United States
Forest Investigative Site 2047
Tampa, Florida, 33613, United States
Forest Investigative Site 1185
Winter Park, Florida, 32789, United States
Forest Investigative Site 1860
Winter Park, Florida, 32792, United States
Forest Investigative Site 1982
Albany, Georgia, 31707, United States
Forest Investigative Site 1900
Atlanta, Georgia, 30312, United States
Forest Investigative Site 0987
Austell, Georgia, 30106, United States
Forest Investigative Site 1828
Canton, Georgia, 30114, United States
Forest Investigative Site 1830
Marietta, Georgia, 30066, United States
Forest Investigative Site 2089
Woodstock, Georgia, 30189, United States
Forest Investigative Site 0679
Coeur d'Alene, Idaho, 83814, United States
Forest Investigative Site 1858
Eagle, Idaho, 83616, United States
Forest Investigative Site 1095
Normal, Illinois, 61761, United States
Forest Investigative Site 1912
Normal, Illinois, 61761, United States
Forest Investigative Site 2051
River Forest, Illinois, 60305, United States
Forest Investigative Site 2033
Bowling Green, Kentucky, 42101, United States
Forest Investigative Site 2085
Fort Mitchell, Kentucky, 41017, United States
Forest Investigative Site 0539
Lexington, Kentucky, 40504, United States
Forest Investigative Site 1478
Louisville, Kentucky, 40217, United States
Forest Investigative Site 1519
Owensboro, Kentucky, 42303, United States
Forest Investigative Site 1811
Covington, Louisiana, 70433, United States
Forest Investigative Site 1430
New Orleans, Louisiana, 70115, United States
Forest Investigative Site 1812
Opelousas, Louisiana, 70570, United States
Forest Investigative Site 1814
Bangor, Maine, 04401, United States
Forest Investigative Site 1924
Baltimore, Maryland, 21237, United States
Forest Investigative Site 1865
Hollywood, Maryland, 20636, United States
Forest Investigative Site 1872
Wheaton, Maryland, 20902, United States
Forest Investigative Site 1570
Fall River, Massachusetts, 02720, United States
Forest Investigative Site 1852
Fall River, Massachusetts, 02720, United States
Forest Investigative Site 1029
North Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site 1431
North Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site 1892
Ann Arbor, Michigan, 48106, United States
Forest Investigative Site 1342
Stevensville, Michigan, 49127, United States
Forest Investigative Site 1487
Troy, Michigan, 48085, United States
Forest Investigative Site 1128
Edina, Minnesota, 55435, United States
Forest Investigative Site 1527
Fridley, Minnesota, 55432, United States
Forest Investigative Site 2041
Minneapolis, Minnesota, 55402, United States
Forest Investigative Site 1124
Minneapolis, Minnesota, 55407, United States
Forest Investigative Site 1619
Plymouth, Minnesota, 55441, United States
Forest Investigative Site 1118
Rochester, Minnesota, 55905, United States
Forest Investigative Site 1884
Olive Branch, Mississippi, 38654, United States
Forest Investigative Site 1587
Chesterfield, Missouri, 63017, United States
Forest Investigative Site 1602
Kansas City, Missouri, 64128, United States
Forest Investigative Site 2079
Saint Charles, Missouri, 63301, United States
Forest Investigative Site 1856
Springfield, Missouri, 65803, United States
Forest Investigative Site 1867
Springfield, Missouri, 65807, United States
Forest Investigative Site 1399
St Louis, Missouri, 63141, United States
Forest Investigative Site 1599
St Louis, Missouri, 63141, United States
Forest Investigative Site 1831
Bozeman, Montana, 59718, United States
Forest Investigative Site 1400
Missoula, Montana, 59808, United States
Forest Investigative Site 1609
Bellevue, Nebraska, 68123, United States
Forest Investigative Site 1948
Fremont, Nebraska, 68025, United States
Forest Investigative Site 1815
Lincoln, Nebraska, 68510, United States
Forest Investigative Site 1363
Omaha, Nebraska, 68114, United States
Forest Investigative Site 1907
Omaha, Nebraska, 68130, United States
Forest Investigative Site 1911
Omaha, Nebraska, 68131, United States
Forest Investigative Site 1908
Omaha, Nebraska, 68134, United States
Forest Investigative Site 1804
Omaha, Nebraska, 68144, United States
Forest Investigative Site 1807
Henderson, Nevada, 89052, United States
Forest Investigative Site 1834
Las Vegas, Nevada, 89128, United States
Forest Investigative Site 1562
Las Vegas, Nevada, 89183, United States
Forest Investigative Site 1559
Cherry Hill, New Jersey, 08003, United States
Forest Investigative Site 1923
Hackensack, New Jersey, 07601, United States
Forest Investigative Site 1949
Albuquerque, New Mexico, 87106, United States
Forest Investigative Site 1151
Great Neck, New York, 11021, United States
Forest Investigative Site 1489
Larchmont, New York, 10538, United States
Forest Investigative Site 0550
New York, New York, 10003, United States
Forest Investigative Site 1425
New York, New York, 10028, United States
Forest Investigative Site 2098
Rochester, New York, 14618, United States
Forest Investigative Site 1392
Charlotte, North Carolina, 28277, United States
Forest Investigative Site 2035
Elizabeth City, North Carolina, 27909, United States
Forest Investigative Site 1366
High Point, North Carolina, 27262, United States
Forest Investigative Site 1153
Raleigh, North Carolina, 27607, United States
Forest Investigative Site 1823
Salisbury, North Carolina, 28144, United States
Forest Investigative Site 1891
Cadiz, Ohio, 43907, United States
Forest Investigative Site 1134
Canton, Ohio, 44718, United States
Forest Investigative Site 1885
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 1806
Cincinnati, Ohio, 45231, United States
Forest Investigative Site 2028
Cincinnati, Ohio, 45242, United States
Forest Investigative Site 1903
Cincinnati, Ohio, 45245, United States
Forest Investigative Site 1361
Columbus, Ohio, 43207, United States
Forest Investigative Site 1433
Columbus, Ohio, 43213, United States
Forest Investigative Site 2090
Sylvania, Ohio, 43560, United States
Forest Investigative Site 1530
Toledo, Ohio, 43608, United States
Forest Investigative Site 1393
Zanesville, Ohio, 43701, United States
Forest Investigative Site 1915
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 1889
Bend, Oregon, 97701, United States
Forest Investigative Site 2043
Medford, Oregon, 97504, United States
Forest Investigative Site 1833
Altoona, Pennsylvania, 16601, United States
Forest Investigative Site 1855
Clairton, Pennsylvania, 15025, United States
Forest Investigative Site 1820
Downington, Pennsylvania, 19335, United States
Forest Investigative Site 1423
Erie, Pennsylvania, 16508, United States
Forest Investigative Site 1899
Langhorne, Pennsylvania, 19047, United States
Forest Investigative Site 1443
Philadelphia, Pennsylvania, 19107, United States
Forest Investigative Site 1863
Phoenixville, Pennsylvania, 19460, United States
Forest Investigative Site 1146
Pittsburgh, Pennsylvania, 15243, United States
Forest Investigative Site 1449
Tipton, Pennsylvania, 16684, United States
Forest Investigative Site 1862
Uniontown, Pennsylvania, 15473, United States
Forest Investigative Site 1832
Cumberland, Rhode Island, 02864, United States
Forest Investigative Site 1089
East Providence, Rhode Island, 02914, United States
Forest Investigative Site 2072
Charleston, South Carolina, 29406, United States
Forest Investigative Site 1905
Charleston, South Carolina, 29407, United States
Forest Investigative Site 1802
Charleston, South Carolina, 29412, United States
Forest Investigative Site 1914
Fort Mill, South Carolina, 29707, United States
Forest Investigative Site 1913
Gaffney, South Carolina, 29340, United States
Forest Investigative Site 1121
Spartanburg, South Carolina, 29303, United States
Forest Investigative Site 1957
Brentwood, Tennessee, 37027, United States
Forest Investigative Site 1526
Fayetteville, Tennessee, 37334, United States
Forest Investigative Site 1440
Arlington, Texas, 76012, United States
Forest Investigative Site 1879
Boerne, Texas, 78006, United States
Forest Investigative Site 1861
Carrollton, Texas, 75007, United States
Forest Investigative Site 1816
Corsicana, Texas, 75110, United States
Forest Investigative Site 1890
Dallas, Texas, 75220, United States
Forest Investigative Site 1332
El Paso, Texas, 79903, United States
Forest Investigative Site 2012
Fort Worth, Texas, 76104, United States
Forest Investigative Site 1951
Houston, Texas, 77070, United States
Forest Investigative Site 1902
Killeen, Texas, 76543, United States
Forest Investigative Site 1091
McKinney, Texas, 75069, United States
Forest Investigative Site 1826
Plano, Texas, 75001, United States
Forest Investigative Site 0526
San Angelo, Texas, 76904, United States
Forest Investigative Site 1895
San Antonio, Texas, 78212, United States
Forest Investigative Site 1936
Salt Lake City, Utah, 84102, United States
Forest Investigative Site 1330
South Burlington, Vermont, 25403, United States
Forest Investigative Site 1945
Newport News, Virginia, 23606, United States
Forest Investigative Site 1404
Norfolk, Virginia, 23502, United States
Forest Investigative Site 1120
Bellingham, Washington, 98225, United States
Forest Investigative Site 1977
Spokane, Washington, 99202, United States
Forest Investigative Site 1878
Spokane, Washington, 99204, United States
Forest Investigative Site 1573
Spokane, Washington, 99216, United States
Forest Investigative Site 0988
Tacoma, Washington, 98405, United States
Forest Investigative Site 1870
Tacoma, Washington, 98405, United States
Forest Investigative Site 1555
Morgantown, West Virginia, 26505, United States
Forest Investigative Site 1991
New Lambton, New South Wales, 2305, Australia
Forest Investigative Site 1987
Redcliffe, Queensland, 4020, Australia
Forest Investigative Site 1973
Woolloongabba, Queensland, 4102, Australia
Forest Investigative Site 1981
Bedford Park, South Australia, 5042, Australia
Forest Investigative Site 1990
Daw Park, South Australia, 5041, Australia
Forest Investigative Site 2251
Toorak Gardens, South Australia, 5065, Australia
Forest Investigative Site 2250
Clayton, Victoria, 3168, Australia
Forest Investigative Site 1972
Fitzroy, Victoria, 3011, Australia
Forest Investigative Site 1986
Geelong, Victoria, 3220, Australia
Forest Investigative Site 1985
Parkville, Victoria, 3050, Australia
Forest Investigative Site 2253
Adelaide, Western Australia, 5000, Australia
Forest Investigative Site 1904
Langley, British Columbia, V3A 4H9, Canada
Forest Investigative Site 0905
Vancouver, British Columbia, V5Z 1M9, Canada
Forest Investigative Site 0976
Winnipeg, Manitoba, R2K 3S8, Canada
Forest Investigative Site 1877
Sarina, Ontario, N7T 4X3, Canada
Forest Investigative Site 1896
Sarnia, Ontario, N7T 4X3, Canada
Forest Investigative Site 1171
Toronto, Ontario, M5T 3A9, Canada
Forest Investigative Site 2203
Toronto, Ontario, M6H 3M2, Canada
Forest Investigative Site 1952
Montreal, Quebec, H2R 1V6, Canada
Forest Investigative Site 1859
Québec, Quebec, G1V 4M6, Canada
Forest Investigative Site 0943
Saskatoon, Saskatchewan, S7N0W8, Canada
Forest Investigative Site 1027
Auckland, 1051, New Zealand
Forest Investigative Site 1970
Christchurch, 8011, New Zealand
Forest Investigative Site 1967
Dunedin, 9012, New Zealand
Forest Investigative Site 1964
Dunedin, 9058, New Zealand
Forest Investigative Site 1968
Hamilton, 3240, New Zealand
Forest Investigative Site 1965
Tauranga, 3110, New Zealand
Forest Investigative Site 1980
Tauranga, 3112, New Zealand
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Wellington, 7366, New Zealand
Related Publications (5)
Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naive Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019.
PMID: 31827323DERIVEDSingh D, D'Urzo AD, Chuecos F, Munoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.
PMID: 28558833DERIVEDJones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
PMID: 27215749DERIVEDBateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16(1):92. doi: 10.1186/s12931-015-0250-2.
PMID: 26233481DERIVEDD'Urzo AD, Rennard SI, Kerwin EM, Mergel V, Leselbaum AR, Caracta CF; AUGMENT COPD study investigators. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014 Oct 14;15(1):123. doi: 10.1186/s12931-014-0123-0.
PMID: 25756831DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- Study Information Center
Study Officials
- STUDY DIRECTOR
Esther Garcia, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2011
First Posted
September 20, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 23, 2017
Results First Posted
March 23, 2017
Record last verified: 2017-01