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

Use our guide to learn which trials are right for you!

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
Sarasota, Florida 34239
874
mi
from 43215
Sarasota, FL
Click here to add this to my saved trials
*See Various Dept.'s*, Arizona
1594
mi
from 43215
*See Various Dept.'s*, AZ
Click here to add this to my saved trials
Arlington, Texas 76012
928
mi
from 43215
Arlington, TX
Click here to add this to my saved trials
Barranquilla, Atlantico
2063
mi
from 43215
Barranquilla,
Click here to add this to my saved trials
Brandon, New Jersey 33511
834
mi
from 43215
Brandon, NJ
Click here to add this to my saved trials
Buena Park, California 90620
1965
mi
from 43215
Buena Park, CA
Click here to add this to my saved trials
Charleston, South Carolina 29407
525
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29407
525
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29407
525
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
360
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Clearwater, Florida 33756
830
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
Clearwater, Florida 33756
830
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
Columbia, South Carolina 29201
427
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
Corsicana, Texas 75110
925
mi
from 43215
Corsicana, TX
Click here to add this to my saved trials
Dallas, Texas 75216
914
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75216
914
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75216
914
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Deland, Florida 32720
761
mi
from 43215
Deland, FL
Click here to add this to my saved trials
Easley, South Carolina 29640
355
mi
from 43215
Easley, SC
Click here to add this to my saved trials
Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
Ft. Lauderdale, Florida 33316
972
mi
from 43215
Ft. Lauderdale, FL
Click here to add this to my saved trials
Ft. Worth, Texas 76104
937
mi
from 43215
Ft. Worth, TX
Click here to add this to my saved trials
Fullerton, California 92835
1959
mi
from 43215
Fullerton, CA
Click here to add this to my saved trials
Gaffney, South Carolina 29340
346
mi
from 43215
Gaffney, SC
Click here to add this to my saved trials
Greenville, South Carolina 29605
360
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
Henderson, Nevada 89014
1754
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
Huntersville, North Carolina 28078
336
mi
from 43215
Huntersville, NC
Click here to add this to my saved trials
Huntsville, Alabama 35801
409
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
Johnson City, Tennessee 37604
256
mi
from 43215
Johnson City, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89135
1756
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
418
mi
from 43215
Lawrenceville, GA
Click here to add this to my saved trials
Lufkin, Texas 75904
885
mi
from 43215
Lufkin, TX
Click here to add this to my saved trials
Lufkin, Texas 75904
885
mi
from 43215
Lufkin, TX
Click here to add this to my saved trials
McKinney, Texas 75069
885
mi
from 43215
McKinney, TX
Click here to add this to my saved trials
Miami, Florida 33136
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33136
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Opelousas, Louisiana 70570
827
mi
from 43215
Opelousas, LA
Click here to add this to my saved trials
Orlando, Florida 32806
797
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Palmdale, California 93551
1955
mi
from 43215
Palmdale, CA
Click here to add this to my saved trials
Pelzer, South Carolina 29669
369
mi
from 43215
Pelzer, SC
Click here to add this to my saved trials
Pensacola, Florida 32504
695
mi
from 43215
Pensacola, FL
Click here to add this to my saved trials
Pensacola, Florida 32504
695
mi
from 43215
Pensacola, FL
Click here to add this to my saved trials
Port Orange, Florida 32127
758
mi
from 43215
Port Orange, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27609
372
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
Reno, Nevada 89502
1936
mi
from 43215
Reno, NV
Click here to add this to my saved trials
Riverside, California 92506
1929
mi
from 43215
Riverside, CA
Click here to add this to my saved trials
Rock Hll, South Carolina 29732
365
mi
from 43215
Rock Hll, SC
Click here to add this to my saved trials
San Diego, California 92123
1947
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
Seneca, South Carolina 29678
364
mi
from 43215
Seneca, SC
Click here to add this to my saved trials
Sepulveda, California 91343
1979
mi
from 43215
Sepulveda, CA
Click here to add this to my saved trials
Shelby, North Carolina 28152
332
mi
from 43215
Shelby, NC
Click here to add this to my saved trials
Shelby, North Carolina 28152
332
mi
from 43215
Shelby, NC
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
363
mi
from 43215
Simpsonville, SC
Click here to add this to my saved trials
Spartanburg, South Carolina 29302
351
mi
from 43215
Spartanburg, SC
Click here to add this to my saved trials
Tamarac, Florida 33321
963
mi
from 43215
Tamarac, FL
Click here to add this to my saved trials
Tampa, Florida 33613
821
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Tempe, Arizona 85283
1657
mi
from 43215
Tempe, AZ
Click here to add this to my saved trials
Tyler, Texas 75701
863
mi
from 43215
Tyler, TX
Click here to add this to my saved trials
Union, South Carolina 29379
372
mi
from 43215
Union, SC
Click here to add this to my saved trials
Winter Park, Florida 32789
791
mi
from 43215
Winter Park, FL
Click here to add this to my saved trials