An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: tiotropium

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00365560

205.341

Details and patient eligibility

About

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history < 10 pack years and >= 1 year smoking cessation; Patients must be symptomatic

Exclusion criteria

Patients

with a recent history (i.e., six months or less) of myocardial infarction,
who have been hospitalized for heart failure (NYHA class III or IV) within the past year,
with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,
with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,
who have undergone thoracotomy with pulmonary resection,
with moderate to severe renal impairment (creatinine clearance = 50 mL/min)