Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
| NCT number | NCT00274547 |
| Other study ID # | 205.266 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | January 9, 2006 |
| Last updated | October 31, 2013 |
| Start date | September 2001 |
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
| Status | Completed |
| Enrollment | 1829 |
| Est. completion date | |
| Est. primary completion date | February 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Respiratory Diseases (111A) | Bay Pines | Florida |
| United States | Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | Boehringer Ingelheim Investigational Site | Buffalo | New York |
| United States | Dallas VAMC | Dallas | Texas |
| United States | Boehringer Ingelheim Investigational Site | Durham | North Carolina |
| United States | J. Hillis Miller Health Center | Gainesville | Florida |
| United States | Hampton VA Medical Center | Hampton | Virginia |
| United States | Veteran Affairs Medical Center | Hines | Illinois |
| United States | Veterans Affairs Medical Center | Houston | Texas |
| United States | Boehringer Ingelheim Investigational Site | Indianapolis | Indiana |
| United States | Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | Boehringer Ingelheim Investigational Site | Lexington | Kentucky |
| United States | VA Long Beach Healthcare System | Long Beach | California |
| United States | 4720 I-10 Service Road | Metairie | Louisiana |
| United States | Veteran Affairs Medical Center | Minneapolis | Minnesota |
| United States | Bronx VA Medical Center | New York | New York |
| United States | Veterans Affairs Medical Center | North Chicago | Illinois |
| United States | Boehringer Ingelheim Investigational Site | Omaha | Nebraska |
| United States | Boehringer Ingelheim Investigational Site | Palo Alto | California |
| United States | Carl T. Hayden VA Medical Center | Phoenix | Arizona |
| United States | Boehringer Ingelheim Investigational Site | Reno | Nevada |
| United States | Hunter Holmes McGuire Medical Center | Richmond | Virginia |
| United States | Boehringer Ingelheim Investigational Site | Salt Lake City | Utah |
| United States | Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | Southern Arizona VA Health Care System | Tuscon | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients experiencing an exacerbation | 6 months | No | |
| Primary | Percentage of patients hospitalized for a COPD exacerbation | 6 months | No | |
| Secondary | Time to first COPD exacerbation | 6 months | No | |
| Secondary | Time to first hospitalization associated with an COPD exacerbation | 6 months | No | |
| Secondary | Total number of days of corticosteroids for an COPD exacerbation | 6 months | No | |
| Secondary | Total number of antibiotics for an COPD exacerbation | 6 months | No | |
| Secondary | Number of unscheduled out-patient visits | 6 months | No | |
| Secondary | Total number of hospital admissions and total hospital days | 6 months | No | |
| Secondary | Trough post-dose FEV1 and FVC | after 3 and 6 months | No | |
| Secondary | 90 minute post-dose FEV1 and FVC | after 3 and 6 months | No | |
| Secondary | Occurrence of serious adverse events | 6 months | No |
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