Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Key facts

Study ID

NCT00144339

Run by

Boehringer Ingelheim

People needed

5993

Starts

2002-12-01

Last updated by the study team

2014-05-20

Who can join

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

You may qualify if…

• Written informed consent.
• Male or female patients 40 years of age or older.
• Smoking history of at least 10 pack years.
• Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

You may not qualify if…

• Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
• Myocardial infarction in past 6 months.
• Unstable or life threatening arrhythmia in past year.
• Hospitalization for NYHA heart failure class III or IV in past year.
• Active tuberculosis.
• Asthma.
• Pulmonary resection.
• Malignancy treated with radiation or chemotherapy in past 5 years.
• Respiratory infection in 4 weeks prior to screening.
• Known hypersensitivity to anticholinergic drugs or components.
• Known moderate to severe renal impairment.
• Known narrow angle glaucoma.
• Significant symptomatic BPH or bladder neck obstruction.
• Need for oxygen therapy >12 hr/day.
• Use of oral corticosteroids at unstable doses or >10 mg/day.

Where it is running

• 205.235.3785 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 205.235.3804 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
• 205.235.3795 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 205.235.3759 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 205.235.3770 Boehringer Ingelheim Investigational Site — Carmichael, California, United States
• 205.235.3778 Boehringer Ingelheim Investigational Site — Escondito, California, United States
• 205.235.3810 Boehringer Ingelheim Investigational Site — Lakewood, California, United States
• 205.235.3758 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 205.235.3812 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 205.235.3773 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 205.235.3800 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 205.235.3802 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 205.235.3786 Pulmonary and Critical Care Medicine — Orange, California, United States
• 205.235.3811 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 205.235.3741 Boehringer Ingelheim Investigational Site — Rancho Mirage, California, United States
• 205.235.3717 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.235.3781 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.235.3784 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.235.3760 Boehringer Ingelheim Investigational Site — Sepulveda, California, United States
• 205.235.3711 Boehringer Ingelheim Investigational Site — Stockton, California, United States
• 205.235.3764 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 205.235.3783 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 205.235.3727 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
• 205.235.3808 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
• 205.235.3779 Boehringer Ingelheim Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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