Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: 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

Inclusion Criteria

Not provided

Exclusion Criteria

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 plan
Change 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 estimate
Percentage 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
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Montgomery, Alabama, United States
205.478.00208 Boehringer Ingelheim Investigational Site
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Flagstaff, Arizona, United States
205.478.00260 Boehringer Ingelheim Investigational Site
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Glendale, Arizona, United States
205.478.00241 Boehringer Ingelheim Investigational Site
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Loma Linda, California, United States
205.478.00240 Boehringer Ingelheim Investigational Site
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Long Beach, California, United States
205.478.00237 Boehringer Ingelheim Investigational Site
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Torrance, California, United States
205.478.00231 Boehringer Ingelheim Investigational Site
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Denver, Colorado, United States
205.478.00209 Boehringer Ingelheim Investigational Site
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Danbury, Connecticut, United States
205.478.00250 Boehringer Ingelheim Investigational Site
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Glastonbury, Connecticut, United States
205.478.00229 Boehringer Ingelheim Investigational Site
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Hartford, Connecticut, United States
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205.478.00243 Boehringer Ingelheim Investigational Site
🇺🇸Montgomery, Alabama, United States