Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: tiotropium bromide

Registration Number: NCT01663987

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 1)

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 capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
18 mcg tiotropium	tiotropium bromide	Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug	Baseline and 12 weeks	Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years	Percentage 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, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead. This endpoint was analysed using combined data, as specified in the analysis plan.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	Baseline and 12 weeks	Change from baseline of Trough FEV1 (forced expiratory volume in one 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. This endpoint was analysed using combined data, as specified in the analysis plan.
Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years	Percentage 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 a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors). This endpoint was analysed using combined data, as specified in the analysis plan.
Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	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. This endpoint was analysed using combined data, as specified in the analysis plan.
Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	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.
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.
Percentage of Patients With Adverse Clinical Event on Study	From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years	Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.
Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	Baseline and 12 weeks	Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug. This endpoint was analysed using combined data, as specified in the analysis plan.
Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years	Percentage 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. This endpoint was analysed using combined data, as specified in the analysis plan.
Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	from date of hospital discharge prior to randomization up to readmission days >1 and <31 days	Percentage 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. This endpoint was analysed using combined data, as specified in the analysis plan.
Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)	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. This endpoint was analysed using combined data, as specified in the analysis plan.

Trial Locations

Locations (50): 205.477.001039 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
205.477.001050 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
205.477.001021 Boehringer Ingelheim Investigational Site
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Florence, Alabama, United States
205.477.001046 Boehringer Ingelheim Investigational Site
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Fountain Valley, California, United States
205.477.001052 Boehringer Ingelheim Investigational Site
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Sacramento, California, United States
205.477.001059 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
205.477.001009 Boehringer Ingelheim Investigational Site
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Stamford, Connecticut, United States
205.477.001040 Boehringer Ingelheim Investigational Site
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Waterbury, Connecticut, United States
205.477.001051 Boehringer Ingelheim Investigational Site
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Brandon, Florida, United States
205.477.001044 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
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205.477.001039 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States