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

Boehringer Ingelheim79 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium bromideDRUG

18 mcg once a day (QD)

PlaceboDRUG

once a day (QD)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria: The following inclusion criteria apply at Visit 0: 1. All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures. 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). The following inclusion criteria apply at Visit 1: 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: The following exclusion criterion applies at Visit 0: 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 The following exclusion criteria apply at Visit 1: 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.

Locations (50)

Outcomes

Primary Outcomes

Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug

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.

Time frame: Baseline and 12 weeks

Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)

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.

Time frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years

Secondary Outcomes

Change From Baseline of Trough FVC at 12 Weeks on Study Drug

Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.

Time frame: Baseline and 12 weeks

Percentage of Patients With Adverse Clinical Event on Study

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.

Time frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years

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)

Data from ClinicalTrials.gov

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205.477.001039 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

205.477.001050 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

205.477.001021 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

205.477.001046 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

205.477.001052 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

205.477.001059 Boehringer Ingelheim Investigational Site

San Diego, California, United States

205.477.001009 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

205.477.001040 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

205.477.001051 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

205.477.001044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

...and 40 more locations