Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
NCT ID: NCT01662986
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
2014-04-01
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 bromide
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 inhalation powder capsule daily (in the morning) 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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205.478.00243 Boehringer Ingelheim Investigational Site
Montgomery, Alabama, United States
205.478.00208 Boehringer Ingelheim Investigational Site
Flagstaff, Arizona, United States
205.478.00260 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
205.478.00241 Boehringer Ingelheim Investigational Site
Loma Linda, California, United States
205.478.00240 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
205.478.00237 Boehringer Ingelheim Investigational Site
Torrance, California, United States
205.478.00231 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
205.478.00209 Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
205.478.00250 Boehringer Ingelheim Investigational Site
Glastonbury, Connecticut, United States
205.478.00229 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
205.478.00200 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
205.478.00212 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
205.478.00265 Boehringer Ingelheim Investigational Site
Kissimmee, Florida, United States
205.478.00246 Boehringer Ingelheim Investigational Site
Lehigh Acres, Florida, United States
205.478.00248 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
205.478.00215 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
205.478.00261 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
205.478.00233 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
205.478.00236 Boehringer Ingelheim Investigational Site
Austell, Georgia, United States
205.478.00205 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia, United States
205.478.00225 Boehringer Ingelheim Investigational Site
Evanston, Illinois, United States
205.478.00264 Boehringer Ingelheim Investigational Site
Iowa City, Iowa, United States
205.478.00254 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
205.478.00249 Boehringer Ingelheim Investigational Site
Topeka, Kansas, United States
205.478.00257 Boehringer Ingelheim Investigational Site
Hazard, Kentucky, United States
205.478.00234 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
205.478.00242 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
205.478.00258 Boehringer Ingelheim Investigational Site
Eunice, Louisiana, United States
205.478.00256 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
205.478.00210 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
205.478.00220 Boehringer Ingelheim Investigational Site
Towson, Maryland, United States
205.478.00204 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
205.478.00247 Boehringer Ingelheim Investigational Site
Winston Salem, Massachusetts, United States
205.478.00263 Boehringer Ingelheim Investigational Site
Rochester, Minnesota, United States
205.478.00201 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
205.478.00239 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
205.478.00227 Boehringer Ingelheim Investigational Site
Summit, New Jersey, United States
205.478.00253 Boehringer Ingelheim Investigational Site
The Bronx, New York, United States
205.478.00226 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
205.478.00232 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
205.478.00203 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
205.478.00206 Boehringer Ingelheim Investigational Site
Wyomissing, Pennsylvania, United States
205.478.00219 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
205.478.00222 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
205.478.00235 Boehringer Ingelheim Investigational Site
Kingwood, Texas, United States
205.478.00217 Boehringer Ingelheim Investigational Site
McKinney, Texas, United States
205.478.00216 Boehringer Ingelheim Investigational Site
Temple, Texas, United States
205.478.00230 Boehringer Ingelheim Investigational Site
Falls Church, Virginia, United States
205.478.00202 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
205.478.00224 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Countries
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Other Identifiers
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205.478
Identifier Type: -
Identifier Source: org_study_id
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