Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1
NCT ID: NCT01663987
Last Updated: 2018-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
79 participants
INTERVENTIONAL
2012-08-01
2014-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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18 mcg tiotropium
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
tiotropium bromide
18 mcg once a day (QD)
Placebo
Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Placebo
once a day (QD)
Interventions
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tiotropium bromide
18 mcg once a day (QD)
Placebo
once a day (QD)
Eligibility Criteria
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Inclusion Criteria
2. Male or female subjects 40 years of age or older.
3. Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days. Determination of accuracy of admission diagnosis will be at the discretion of the investigator.
4. Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).
5. Discharged from the hospital =10 days from date of randomization.
6. All subjects must have a diagnosis of COPD (P12-01205), and have documented airway obstruction with a post-bronchodilator Force expiratory volume in 1 second (FEV1)/Force vital capacity (FVC )\<0.7(See Section 5.1.2, Pulmonary Function Testing). The diagnosis of COPD can be made at Visit 1 if no Pulmonary Function Testing (PFT) data available within the past 12 months.
7. Subjects must be current or ex-smoker with a smoking history of =10 pack-years:
Pack-years = Number of cigarettes/day x years of smoking 20 cigarettes/ pack 8. Subjects must be able to inhale medication in a competent manner from the HandiHaler® device (Appendix 10.1) and from a metered dose inhaler (MDI).
Exclusion Criteria
1. No more than 30 days of therapy with any long-acting inhaled anticholinergic over preceding 3 months prior to discharge from the hospital, and no therapy with any long acting anticholinergic post discharge (no use between hospital discharge and randomization) or any other restricted concomitant medications
2. Presence of a significant disease (in the opinion of the investigator) which may put the subject at risk because of participation in the study or may influence the subject's ability to participate in the study for up to 2 years.
3. A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
5. Subjects with asthma (subject treated for asthma in the last 2 years, history of childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary thromboembolic disease or known active tuberculosis.
7\. Malignancy for which the subject has undergone resection, radiation, chemotherapy or biological treatments within the last two years or is currently on active radiation therapy, chemotherapy or biological treatment. Subjects with treated basal cell carcinoma and non-invasive squamous cell skin carcinoma are allowed.
8\. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.
9\. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
10\. Known moderate to severe renal impairment as judged by the investigator. 11. Known narrow angle glaucoma as judged by the investigator. 12. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms are controlled on treatment may be included. 13. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or sub dermal implants e.g., Norplant) for at least three months prior to and for the duration of the trial.
14\. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.
16\. Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.
17\. Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.
18\. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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205.477.001039 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.477.001050 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.477.001021 Boehringer Ingelheim Investigational Site
Florence, Alabama, United States
205.477.001046 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
205.477.001052 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
205.477.001059 Boehringer Ingelheim Investigational Site
San Diego, California, United States
205.477.001009 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
205.477.001040 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
205.477.001051 Boehringer Ingelheim Investigational Site
Brandon, Florida, United States
205.477.001044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
205.477.001037 Boehringer Ingelheim Investigational Site
Eustis, Florida, United States
205.477.001017 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
205.477.001063 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
205.477.001001 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
205.477.001004 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
205.477.001012 Boehringer Ingelheim Investigational Site
Duluth, Georgia, United States
205.477.001064 Boehringer Ingelheim Investigational Site
Belleville, Illinois, United States
205.477.001038 Boehringer Ingelheim Investigational Site
Muncie, Indiana, United States
205.477.001007 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
205.477.001014 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
205.477.001018 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
205.477.001068 Boehringer Ingelheim Investigational Site
Union, New Jersey, United States
205.477.001035 Boehringer Ingelheim Investigational Site
Cooperstown, New York, United States
205.477.001023 Boehringer Ingelheim Investigational Site
New York, New York, United States
205.477.001061 Boehringer Ingelheim Investigational Site
Staten Island, New York, United States
205.477.001027 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
205.477.001032 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
205.477.001020 Boehringer Ingelheim Investigational Site
Seneca, North Carolina, United States
205.477.001034 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
205.477.001053 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
205.477.001011 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
205.477.001057 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
205.477.001006 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
205.477.001083 Boehringer Ingelheim Investigational Site
Downingtown, Pennsylvania, United States
205.477.001031 Boehringer Ingelheim Investigational Site
Monroeville, Pennsylvania, United States
205.477.001028 Boehringer Ingelheim Investigational Site
Anderson, South Carolina, United States
205.477.001019 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
205.477.001010 Boehringer Ingelheim Investigational Site
Fort Mill, South Carolina, United States
205.477.001025 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
205.477.001002 Boehringer Ingelheim Investigational Site
Rock Hill, South Carolina, United States
205.477.001026 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
205.477.001015 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
205.477.001013 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
205.477.001022 Boehringer Ingelheim Investigational Site
Corsicana, Texas, United States
205.477.001055 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
205.477.001054 Boehringer Ingelheim Investigational Site
Katy, Texas, United States
205.477.001062 Boehringer Ingelheim Investigational Site
Tyler, Texas, United States
205.477.001030 Boehringer Ingelheim Investigational Site
Abingdon, Virginia, United States
205.477.001008 Boehringer Ingelheim Investigational Site
Roanoke, Virginia, United States
205.477.001043 Boehringer Ingelheim Investigational Site
San Juan, , Puerto Rico
Countries
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Other Identifiers
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205.477
Identifier Type: -
Identifier Source: org_study_id
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