Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: PlaceboDrug: tiotropium bromide
- Registration Number
- NCT01662986
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler 18 mcg tiotropium bromide tiotropium bromide Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
- Primary Outcome Measures
Name Time Method Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987). from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.
Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed.
This endpoint was analysed using combined data, as specified in the analysis planChange From Baseline of Trough FEV1 at 12 Weeks on Study Drug. Baseline and 12 weeks Change from baseline of trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Adverse Clinical Event During on Study. from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Percentage (number) of patients with adverse clinical event on study, which is defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.
Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) from date of hospital discharge prior to randomization upto readmission days >1 and <31 days Percentage (number) of patients with 30-day hospital readmission rates outcome events was analysed.
Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.
The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days \>1 and \<31 days using the TS.Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) Baseline and week 12 Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.Change From Baseline of Trough FVC at 12 Weeks on Study Drug. baseline and 12 weeks Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) Baseline and week 12 Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years Total patient year exposure of COPD was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.
Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) from first drug administration to the last timepoint with information of EXACT-PRO, Up to 2 years Time to event: Time to recovery based on EXACT-PRO total score. The percentage of observed patients recovered by end of study was reported.
Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.
Analysis based on Kaplan Meier estimatePercentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Percentage (number) of patients with COPD exacerbation on study was analysed for the combined study.
A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following:
1) Shortness of breath; 2) Sputum production (volume) ; 3) Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness.
Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.
A required change in treatment included either prescription of antibiotics and/or systemic steroids; and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines and PDE4-inhibitors).Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987). from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Percentage (number) of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.
All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures.
Hospitalizations occurring on the same day as discharge were not considered a separate admission.Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987) from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years Total patient year exposure of all-cause hospitalization was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.
Trial Locations
- Locations (50)
205.478.00243 Boehringer Ingelheim Investigational Site
🇺🇸Montgomery, Alabama, United States
205.478.00240 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
205.478.00205 Boehringer Ingelheim Investigational Site
🇺🇸Lawrenceville, Georgia, United States
205.478.00236 Boehringer Ingelheim Investigational Site
🇺🇸Austell, Georgia, United States
205.478.00264 Boehringer Ingelheim Investigational Site
🇺🇸Iowa City, Iowa, United States
205.478.00257 Boehringer Ingelheim Investigational Site
🇺🇸Hazard, Kentucky, United States
205.478.00234 Boehringer Ingelheim Investigational Site
🇺🇸Lexington, Kentucky, United States
205.478.00253 Boehringer Ingelheim Investigational Site
🇺🇸Bronx, New York, United States
205.478.00206 Boehringer Ingelheim Investigational Site
🇺🇸Wyomissing, Pennsylvania, 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
205.478.00224 Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
205.478.00241 Boehringer Ingelheim Investigational Site
🇺🇸Loma Linda, California, United States
205.478.00237 Boehringer Ingelheim Investigational Site
🇺🇸Torrance, California, United States
205.478.00229 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
205.478.00225 Boehringer Ingelheim Investigational Site
🇺🇸Evanston, Illinois, United States
205.478.00201 Boehringer Ingelheim Investigational Site
🇺🇸Chesterfield, Missouri, United States
205.478.00232 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
205.478.00203 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
205.478.00219 Boehringer Ingelheim Investigational Site
🇺🇸Easley, South Carolina, United States
205.478.00222 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
205.478.00260 Boehringer Ingelheim Investigational Site
🇺🇸Glendale, Arizona, United States
205.478.00209 Boehringer Ingelheim Investigational Site
🇺🇸Danbury, Connecticut, United States
205.478.00250 Boehringer Ingelheim Investigational Site
🇺🇸Glastonbury, Connecticut, United States
205.478.00258 Boehringer Ingelheim Investigational Site
🇺🇸Eunice, Louisiana, 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
205.478.00233 Boehringer Ingelheim Investigational Site
🇺🇸Vero Beach, Florida, United States
205.478.00261 Boehringer Ingelheim Investigational Site
🇺🇸Saint Petersburg, Florida, United States
205.478.00210 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
205.478.00247 Boehringer Ingelheim Investigational Site
🇺🇸Winston Salem, Massachusetts, 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
205.478.00227 Boehringer Ingelheim Investigational Site
🇺🇸Summit, New Jersey, United States
205.478.00208 Boehringer Ingelheim Investigational Site
🇺🇸Flagstaff, Arizona, United States
205.478.00248 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
205.478.00249 Boehringer Ingelheim Investigational Site
🇺🇸Topeka, Kansas, United States
205.478.00254 Boehringer Ingelheim Investigational Site
🇺🇸Olathe, Kansas, United States
205.478.00215 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
205.478.00231 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
205.478.00242 Boehringer Ingelheim Investigational Site
🇺🇸Louisville, Kentucky, United States
205.478.00256 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
205.478.00263 Boehringer Ingelheim Investigational Site
🇺🇸Rochester, Minnesota, United States
205.478.00239 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, United States
205.478.00226 Boehringer Ingelheim Investigational Site
🇺🇸Chapel Hill, North Carolina, United States
205.478.00202 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States