Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD)
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 07, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium inhalation capsules (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Summary
A 24 week, randomized, double-blind, placebo controlled, multicenter study to evaluate the efficacy and safety of 18 MCG of tiotropium inhalation capsues 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.
Clinical Details
Official title:
A 24 Week, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsues 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.
Study design: Interventional, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study).
Secondary outcome: FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor physicians and patient global assessments Work productivity Use of rescue medication and prn
albuterol (salbutamol)
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA:
- All subjects must have a diagnosis of COPD according to GOLD guideline criteria: post-bronchodilator 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
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site, Palo Alto, California, United States
Boehringer Ingelheim Investigational Site, Lexington, Kentucky, United States
Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States
Boehringer Ingelheim Investigational Site, Rochesrter, Minnesota, United States
Boehringer Ingelheim Investigational Site, Rochester, Minnesota, United States
Boehringer Ingelheim Investigational Site, Hackensack, New Jersey, United States
Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States
Boehringer Ingelheim Investigational Site, Rochester, New York, United States
Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States
Boehringer Ingelheim Investigational Site, Houston, Texas, United States
Additional Information
Ending date: April 2009
Last updated: April 20, 2007
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