Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bronchodilator Agents; Fenoterol; Ipratropium; Tiotropium Bromide

Criteria

Inclusion:

• diagnosis of COPD

• FEV1 < 60% of predicted

• FEV1 < 70% of FVC

• smoking history of 10 pack-years

Exclusion:

• significant other disease than COPD

• history of asthma, allergic rhinitis or blood eosinophil count > 600mm3

• cardiac arrhythmia requiring drug therapy

• symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

• recent history of MI (within past year)

• history of cancer within past 5 years

• life-threatening pulmonary obstruction

• cystic fibrosis or bronchiectasis; tuberculosis

• pulmonary resection