Tiotropium In Exercise

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive, Exercise

In brief

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Key facts

Study ID

NCT00525512

Run by

Boehringer Ingelheim

People needed

519

Starts

2007-08-01

Last updated by the study team

2013-12-24

Who can join

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

You may qualify if…

• All patients must sign an informed consent
• Diagnosis of COPD with specific spirometric criteria (determined at study visits)
• Age >= 40 years
• Medical Research Council Dyspnoea score >= 2
• Current or ex-smoker with a >= 10 pack-year smoking history
• Ability to exercise on treadmill

You may not qualify if…

• Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
• Clinical history of asthma
• Use of supplemental oxygen therapy
• Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
• Recent history (<= 12 months) of myocardial infarction
• Unstable or life-threatening cardiac arrhythmia
• Malignancy treated with radiation therapy or chemotherapy in the last 5 years
• Pregnant or nursing women
• Known hypersensitivity to anticholinergic drugs or any component of the study medications
• Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
• Estimated life expectancy < 2 years
• Symptomatic prostatic hyperplasia or bladder neck obstruction
• Known narrow-angle glaucoma
• Any condition that is contraindicated for exercise
• Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
• Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Where it is running

• 205.368.01022 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 205.368.01003 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 205.368.01008 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• 205.368.01017 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
• 205.368.01028 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 205.368.01004 Boehringer Ingelheim Investigational Site — Bay Pines, Florida, United States
• 205.368.01013 Boehringer Ingelheim Investigational Site — North Miami Beach, Florida, United States
• 205.368.01025 Boehringer Ingelheim Investigational Site — Hazard, Kentucky, United States
• 205.368.01029 Boehringer Ingelheim Investigational Site — Biddeford, Maine, United States
• 205.368.01016 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 205.368.01002 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 205.368.01021 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 205.368.01014 Boehringer Ingelheim Investigational Site — Albany, New York, United States
• 205.368.01030 Boehringer Ingelheim Investigational Site — Tulsa, Oklahoma, United States
• 205.368.01018 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 205.368.01027 Boehringer Ingelheim Investigational Site — Gaffney, South Carolina, United States
• 205.368.01019 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
• 205.368.01020 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 205.368.01024 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
• 205.368.01015 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 205.368.54001 Boehringer Ingelheim Investigational Site — Rosario, Argentina
• 205.368.54002 Boehringer Ingelheim Investigational Site — Vicente López, Argentina
• 205.368.55003 Boehringer Ingelheim Investigational Site — Goiânia, Brazil
• 205.368.55004 Boehringer Ingelheim Investigational Site — Porto Alegre - RS, Brazil
• 205.368.01023 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.