Spiriva® Assessment of FEV1 (SAFE)

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to evaluate whether the effect of one year (48 weeks) treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Diagnosis of COPD

• Stable airway obstruction

• FEV1 < or equal to 65% of predicted

• Male or female

• Age > or equal to 40 years

• > or equal to 10 pack year smoking history

• History of exacerbations in the past year

• Able to be trained in the proper use of the HandiHaler®

Exclusion Criteria:

• History of asthma

• Allergic rhinitis or atopy

• Unstable use (6 weeks) of OCS (or > 10 mg daily use)

• History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis

• Patients who had started or stopped an exercise rehabilitation program in the past twelve months

• Thoracotomy with pulmonary resection or lobectomy (LVRS)

• Active tuberculosis

• Use of beta-blockers

• Pregnant, nursing women and women of childbearing potential not using a medically approved means of contraception

• 6 months or less history of myocardial infarction

• Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system

• History of unstable arrhythmia with a life threatening event or change of related therapy during the past year

• History of cancer, other than treated basal cell carcinoma, within the last 12 months

• Clinically relevant abnormal baseline haematology, blood chemistry or urinalysis

• Patients with narrow angle glaucoma

• Patients with symptomatic benign prostatic hypertrophy

• Patients with bladder neck obstruction

• Patients that planned to be out of the country for 8 weeks or more