A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
- NCT00523991
- PHASE4
- INTERVENTIONAL
Last updated: 2014-05-20
Purpose of Trial
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
tiotropium
Placebo
Inclusion criteria:
All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:
post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1).
Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years.
Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.
Exclusion criteria:
Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
17 Locations
Birmingham
205.365.1003 Boehringer Ingelheim Investigational Site
Alabama, United States
Birmingham
205.365.1004 Boehringer Ingelheim Investigational Site
Alabama, United States
Jasper
205.365.1098 Boehringer Ingelheim Investigational Site
Alabama, United States
Palo Alto
205.365.1023 Boehringer Ingelheim Investigational Site
California, United States
San Diego
205.365.1125 Boehringer Ingelheim Investigational Site
California, United States
Lexington
205.365.1024 Boehringer Ingelheim Investigational Site
Kentucky, United States
Baltimore
205.365.1012 Boehringer Ingelheim Investigational Site
Maryland, United States
Bloomington
205.365.1086 Boehringer Ingelheim Investigational Site
Minnesota, United States
Rochester
205.365.1006 Boehringer Ingelheim Investigational Site
Minnesota, United States
Omaha
205.365.1085 Boehringer Ingelheim Investigational Site
Nebraska, United States
Albuquerque
205.365.1010 Boehringer Ingelheim Investigational Site
New Mexico, United States
Rochester
205.365.1007 Boehringer Ingelheim Investigational Site
New York, United States
Charlotte
205.365.1080 Boehringer Ingelheim Investigational Site
North Carolina, United States
Cincinnati
205.365.1118 Boehringer Ingelheim Investigational Site
Ohio, United States
Pittsburgh
205.365.1033 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Kingsport
205.365.1092 Boehringer Ingelheim Investigational Site
Tennessee, United States
Clarksburg
205.365.1122 Boehringer Ingelheim Investigational Site
West Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov