Long Term Safety Study of NVA237 vs QAB149 in COPD Patients



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:October 2012
End Date:November 2014

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A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation

The purpose of the study is to provide long term safety data of NVA237. This study will
assess the safety and tolerability of a single dose strength of NVA237.


Inclusion Criteria:

1. Male or female patients with COPD according to GOLD 2011 who have signed informed
consent.

2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.

3. Current or ex-smokers with a smoking history of at least 10 pack years

4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists

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

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

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

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

6. Patients with a history of asthma.

7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40
years of age.

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

9. Patients with concomitant pulmonary disease

10. Patients with a history of certain cardiovascular co-morbid conditions

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

12. Patients with active pulmonary tuberculosis

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

14. Other protocol-defined inclusion / exclusion criteria may apply
We found this trial at
62
sites
Biddeford, Maine 04005
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Boerne, Texas 78006
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Boerne, TX
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Burke, Virginia 22015
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Calabash, North Carolina 28467
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Charleston, South Carolina 29407
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Charleston, SC
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Clearwater, Florida 33756
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Columbia, South Carolina 29201
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Columbia, SC
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Columbus, Ohio 43205
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Columbus, OH
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Columbus, Ohio 43205
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Couer D'Alene, Idaho 83814
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Edina, Minnesota 55435
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El Paso, Texas 79902
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El Paso, TX
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Eugene, Oregon 97401
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Eugene, OR
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Florence, Kentucky 41042
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Florence, KY
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Fort Collins, Colorado 90728
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Fort Collins, CO
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Fredericksburg, Virginia 22401
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Fredericksburg, VA
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Fremont, Nebraska 68025
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Fridley, Minnesota 55432
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Fridley, MN
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Glastonbury, Connecticut 06033
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Glastonbury, CT
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Greenville, South Carolina 29605
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Greenville, SC
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Greer, South Carolina 29651
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Greer, SC
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Gulf Shores, Alabama 36547
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Gulf Shores, AL
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Henderson, Nevada 89014
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Henderson, NV
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Hialeah, Florida 33012
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Kingwood, Texas 77339
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Kingwood, TX
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Las Vegas, Nevada 89135
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Las Vegas, NV
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Lebanon, New Hampshire 03756
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Madisonville, Kentucky 42431
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Manassas, Virginia 20109
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Manassas, VA
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Marion, Ohio 43302
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Marion, OH
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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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Miami, Florida 33136
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Miami, FL
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Minneapolis, Minnesota 55402
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Mobile, Alabama 36693
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Mobile, AL
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N. Myrtle Beach, South Carolina 29582
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New Orleans, Louisiana 70115
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Newburgh, Indiana 47630
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Newburgh, IN
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Oakland Park, Florida 33334
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Omaha, Nebraska 68144
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Opelousas, Louisiana 70570
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Oregon, Wisconsin 53575
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Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19102
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Richmond, Virginia 23249
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Richmond, Virginia 23249
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Riverside, California 92506
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San Antonio, Texas 78207
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Stamford, Connecticut 06905
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Tabor City, North Carolina 28463
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Topeka, Kansas 66606
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Tucson, Arizona 85745
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Warwick, Rhode Island 02886
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Waterbury, Connecticut 06708
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Wheat Ridge, Colorado 80033
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White River Junction, Vermont 05009
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Worchester, Massachusetts 01608
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Zanesville, Ohio 43701
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