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Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE3

Brief Summary

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 fun...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

December 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

5993 Patients enrolled

Trial Details

Trial ID

NCT00144339

Start Date

December 1 2002

Last Update

May 20 2014

Active Locations (490)

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Page 1 of 123 (490 locations)

1

205.235.3779 Boehringer Ingelheim Investigational Site

Anniston, Alabama, United States

2

205.235.3785 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

3

205.235.3804 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

4

205.235.3795 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States