Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00523991

Run by

Boehringer Ingelheim

People needed

457

Starts

2007-04-01

Last updated by the study team

2014-05-20

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 205.365.1004 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 205.365.1098 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
• 205.365.1023 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 205.365.1125 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.365.1024 Boehringer Ingelheim Investigational Site — Lexington, Kentucky, United States
• 205.365.1012 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 205.365.1086 Boehringer Ingelheim Investigational Site — Bloomington, Minnesota, United States
• 205.365.1006 Boehringer Ingelheim Investigational Site — Rochester, Minnesota, United States
• 205.365.1085 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 205.365.1010 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
• 205.365.1007 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
• 205.365.1080 Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
• 205.365.1118 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 205.365.1033 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
• 205.365.1092 Boehringer Ingelheim Investigational Site — Kingsport, Tennessee, United States
• 205.365.1122 Boehringer Ingelheim Investigational Site — Clarksburg, West Virginia, United States
• 205.365.1103 Boehringer Ingelheim Investigational Site — Gilly, Belgium
• 205.365.1059 Boehringer Ingelheim Investigational Site — Leuven, Belgium
• 205.365.1057 Boehringer Ingelheim Investigational Site — Menen, Belgium
• 205.365.1058 Boehringer Ingelheim Investigational Site — Yvoir, Belgium
• 205.365.1042 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
• 205.365.1056 Boehringer Ingelheim Investigational Site — Kingston, Ontario, Canada
• 205.365.1104 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
• 205.365.1041 Boehringer Ingelheim Investigational Site — Ste-Foy, Quebec, Canada
• 205.365.1003 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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