A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:February 2014

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This study will assess the efficacy, safety and tolerability of indacaterol
maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.


Inclusion Criteria:

- Male and female patients that have signed informed consent and are >/= 40 years of
age.

- Patients with stable COPD according to GOLD 2011.

- Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a
post-bronchodilator FEV1/FVC <0.70.

- Current or ex-smokers who have a smoking history of at least 10 pack years.

- Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

- Patients with Type I or uncontrolled Type II diabetes - Patients with a history of
long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged
(>450 ms for males and females) and confirmed by a central assessor. (These patients
should not be re-screened.)

- Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102.
(These patients should not be re-screened.)

- Patients with a history of malignancy of any organ system, treated or untreated,
within the last five years.

- Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or
moderate-severe renal impairment or urinary retention.

- Patients who had a COPD exacerbation within 6 weeks prior to screening.

- Patients who have a respiratory tract infection within 4 weeks prior to screening.

- Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

- Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms,
including COPD diagnosis, prior to age 40 years.

- Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.

- Patients with concomitant pulmonary disease.

- Patients with a diagnosis of alpha-1 anti-trypsin deficiency.

- Patients with active pulmonary tuberculosis.

- Patients in the active phase of a pulmonary rehabilitation programme.

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
60
sites
Gaffney, South Carolina 29340
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*See Various Dept.'s*, Arizona
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*See Various Dept.'s*, AZ
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Arlington, Texas 76012
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Barranquilla, Atlantico
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Brandon, New Jersey 33511
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Brandon, NJ
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Buena Park, California 90620
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Charleston, South Carolina 29407
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Charleston, SC
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Charleston, South Carolina 29407
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Charleston, SC
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Charlotte, NC
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Clearwater, Florida 33756
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Clearwater, FL
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Clearwater, Florida 33756
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Clearwater, FL
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Columbia, South Carolina 29201
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Columbia, SC
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Corsicana, Texas 75110
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Corsicana, TX
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Dallas, Texas 75216
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Dallas, Texas 75216
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Dallas, Texas 75216
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Deland, Florida 32720
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Easley, South Carolina 29640
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Fort Worth, Texas 76104
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Ft. Lauderdale, Florida 33316
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Ft. Worth, Texas 76104
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Fullerton, California 92835
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Fullerton, CA
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Greenville, South Carolina 29605
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Greenville, SC
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Henderson, Nevada 89014
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Henderson, NV
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Huntersville, North Carolina 28078
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Huntsville, Alabama 35801
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Johnson City, Tennessee 37604
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Las Vegas, Nevada 89135
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Las Vegas, NV
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Lawrenceville, Georgia 30046
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Lawrenceville, GA
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Lufkin, Texas 75904
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Lufkin, TX
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Lufkin, Texas 75904
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McKinney, Texas 75069
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Miami, Florida 33136
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Miami, FL
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Miami, Florida 33136
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Miami, FL
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Opelousas, Louisiana 70570
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Opelousas, LA
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Orlando, Florida 32806
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Orlando, FL
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Palmdale, California 93551
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Palmdale, CA
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Pelzer, South Carolina 29669
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Pelzer, SC
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Pensacola, Florida 32504
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Pensacola, Florida 32504
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Port Orange, Florida 32127
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Raleigh, North Carolina 27609
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Raleigh, NC
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Reno, Nevada 89502
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Riverside, California 92506
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Rock Hll, South Carolina 29732
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San Diego, California 92123
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San Diego, CA
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Sarasota, Florida 34239
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Seneca, South Carolina 29678
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Sepulveda, California 91343
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Sepulveda, CA
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Shelby, North Carolina 28152
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Shelby, North Carolina 28152
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Simpsonville, South Carolina 29681
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Spartanburg, South Carolina 29302
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Tamarac, Florida 33321
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Tampa, Florida 33613
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Tempe, Arizona 85283
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Tyler, Texas 75701
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Union, South Carolina 29379
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Union, SC
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Winter Park, Florida 32789
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