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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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)

Key facts

Study ID

NCT01663987

Run by

Boehringer Ingelheim

People needed

79

Starts

2012-08-01

Expected to finish

2014-05-01

Last updated by the study team

2018-10-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following inclusion criteria apply at Visit 0:
• 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.
• Male or female subjects 40 years of age or older.
• 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.
• 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:
• Discharged from the hospital =10 days from date of randomization.
• 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.
• 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).

You may not qualify if…

• The following exclusion criterion applies at Visit 0:
• 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:
• 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.
• A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
• Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
• 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.
• 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.
• Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.
• Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
• 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.
• Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.
• Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.
• Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.
• Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.

Where it is running

• 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
• 205.477.001037 Boehringer Ingelheim Investigational Site — Eustis, Florida, United States
• 205.477.001017 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 205.477.001063 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 205.477.001001 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 205.477.001004 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 205.477.001012 Boehringer Ingelheim Investigational Site — Duluth, Georgia, United States
• 205.477.001064 Boehringer Ingelheim Investigational Site — Belleville, Illinois, United States
• 205.477.001038 Boehringer Ingelheim Investigational Site — Muncie, Indiana, United States
• 205.477.001007 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 205.477.001014 Boehringer Ingelheim Investigational Site — Columbia, Maryland, United States
• 205.477.001018 Boehringer Ingelheim Investigational Site — Livonia, Michigan, United States
• 205.477.001068 Boehringer Ingelheim Investigational Site — Union, New Jersey, United States
• 205.477.001035 Boehringer Ingelheim Investigational Site — Cooperstown, New York, United States
• 205.477.001023 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 205.477.001061 Boehringer Ingelheim Investigational Site — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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