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)

NCT ID: NCT01437397

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1692 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-02-28

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Aclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg

Group Type: EXPERIMENTAL

Aclidinium Bromide/Formoterol Fumarate

Intervention Type: DRUG

Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day

2

Aclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg

Group Type: EXPERIMENTAL

Aclidinium Bromide/Formoterol Fumarate

Intervention Type: DRUG

Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day

3

Aclidinium monotherapy 400 μg

Group Type: ACTIVE_COMPARATOR

Aclidinium Bromide

Intervention Type: DRUG

Inhaled Aclidinium 400 μg, twice per day

4

Formoterol monotherapy 12 μg

Group Type: ACTIVE_COMPARATOR

Formoterol Fumarate

Intervention Type: DRUG

Inhaled Formoterol 12 μg, twice per day

5

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhaled dose-matched placebo, twice per day

Interventions

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day

Intervention Type: DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day

Intervention Type: DRUG

Aclidinium Bromide

Inhaled Aclidinium 400 μg, twice per day

Intervention Type: DRUG

Formoterol Fumarate

Inhaled Formoterol 12 μg, twice per day

Intervention Type: DRUG

Placebo

Inhaled dose-matched placebo, twice per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Sitting, resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg at Visit 1 and Visit 2
• Unable to use a multidose dry-powder inhaler or a pressurized metered-dose inhaler
• Treatment with any other investigational product within 30 days (or 6 half-lives, whichever was longer) before Visit 1
• Previous participation in a clinical trial with aclidinium bromide in an FDC therapy
• Pregnant or breastfeeding
• Current diagnosis of cancer (present in the patient) other than basal or squamous cell skin cancer. Patients who had a history of cancer must have been cleared before Visit 1 (Screening) on a case-by-case basis
• Patients who did not maintain regular day/night, waking/sleeping cycles (eg, night shift workers)
• Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication (Appendix III of the protocol, which can be found in Appendix 16.1.1 of this report)
• Patients who were unlikely to be compliant with study requirements (eg, take their medication, complete their electronic diaries, attend clinic at the required times)
• Patients who were employees or relatives of employees of the investigative study center, FRI, Almirall, SA, or Pharmaceutical Product Development (PPD, Inc.)
• Patients who had any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study or supported excluding the patient from the study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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

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Florence, Alabama, United States

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Gulf Shores, Alabama, United States

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Jasper, Alabama, United States

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Scottsboro, Alabama, United States

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Glendale, Arizona, United States

Forest Investigative Site 1958

Mesa, Arizona, United States

Forest Investigative Site 1379

Phoenix, Arizona, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Lincoln, California, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

Forest Investigative Site 2009

San Diego, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Vista, California, United States

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Golden, Colorado, United States

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Pueblo, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, United States

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Bay Pines, Florida, United States

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Brandon, Florida, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Edgewater, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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North Miami Beach, Florida, United States

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Oldsmar, Florida, United States

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Ormond Beach, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Saint Cloud, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Winter Park, Florida, United States

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Albany, Georgia, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Canton, Georgia, United States

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Marietta, Georgia, United States

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Woodstock, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Eagle, Idaho, United States

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Normal, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Bowling Green, Kentucky, United States

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Fort Mitchell, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Covington, Louisiana, United States

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New Orleans, Louisiana, United States

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Opelousas, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Hollywood, Maryland, United States

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Wheaton, Maryland, United States

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Fall River, Massachusetts, United States

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Fall River, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Stevensville, Michigan, United States

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Troy, Michigan, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Rochester, Minnesota, United States

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Olive Branch, Mississippi, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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Springfield, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Bozeman, Montana, United States

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Missoula, Montana, United States

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Bellevue, Nebraska, United States

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Fremont, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Hackensack, New Jersey, United States

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Albuquerque, New Mexico, United States

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Great Neck, New York, United States

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Larchmont, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Cadiz, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Sylvania, Ohio, United States

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Toledo, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bend, Oregon, United States

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Medford, Oregon, United States

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Altoona, Pennsylvania, United States

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Clairton, Pennsylvania, United States

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Downington, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Fort Mill, South Carolina, United States

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Gaffney, South Carolina, United States

Forest Investigative Site 1121

Spartanburg, South Carolina, United States

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Brentwood, Tennessee, United States

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Fayetteville, Tennessee, United States

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Arlington, Texas, United States

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Boerne, Texas, United States

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Carrollton, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

Forest Investigative Site 2012

Fort Worth, Texas, United States

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Houston, Texas, United States

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Killeen, Texas, United States

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McKinney, Texas, United States

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Plano, Texas, United States

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San Angelo, Texas, United States

Forest Investigative Site 1895

San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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South Burlington, Vermont, United States

Forest Investigative Site 1945

Newport News, Virginia, United States

Forest Investigative Site 1404

Norfolk, Virginia, United States

Forest Investigative Site 1120

Bellingham, Washington, United States

Forest Investigative Site 1977

Spokane, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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New Lambton, New South Wales, Australia

Forest Investigative Site 1987

Redcliffe, Queensland, Australia

Forest Investigative Site 1973

Woolloongabba, Queensland, Australia

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Bedford Park, South Australia, Australia

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Daw Park, South Australia, Australia

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Toorak Gardens, South Australia, Australia

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Clayton, Victoria, Australia

Forest Investigative Site 1972

Fitzroy, Victoria, Australia

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Geelong, Victoria, Australia

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Parkville, Victoria, Australia

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Adelaide, Western Australia, Australia

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Langley, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Sarina, Ontario, Canada

Forest Investigative Site 1896

Sarnia, Ontario, Canada

Forest Investigative Site 1171

Toronto, Ontario, Canada

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Toronto, Ontario, Canada

Forest Investigative Site 1952

Montreal, Quebec, Canada

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Québec, Quebec, Canada

Forest Investigative Site 0943

Saskatoon, Saskatchewan, Canada

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Auckland, , New Zealand

Forest Investigative Site 1970

Christchurch, , New Zealand

Forest Investigative Site 1967

Dunedin, , New Zealand

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Dunedin, , New Zealand

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Hamilton, , New Zealand

Forest Investigative Site 1965

Tauranga, , New Zealand

Forest Investigative Site 1980

Tauranga, , New Zealand

Forest Investigative Site 1025

Wellington, , New Zealand

Countries

United States; Australia; Canada; New Zealand

References

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.

Reference Type: DERIVED

PMID: 31827323 (View on PubMed)

Singh 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.

Reference Type: DERIVED

PMID: 28558833 (View on PubMed)

Jones 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.

Reference Type: DERIVED

PMID: 27215749 (View on PubMed)

Bateman 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.

Reference Type: DERIVED

PMID: 26233481 (View on PubMed)

D'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.

Reference Type: DERIVED

PMID: 25756831 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4060&filename=CSRsynopsis_redacted.pdf

CSR Synopsis

Other Identifiers

LAC-MD-31

Identifier Type: -

Identifier Source: org_study_id