Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hosptal, Baselland; University Hospital, Basel, Switzerland
• Treatments: Budesonide; Tiotropium Bromide

Criteria

Inclusion Criteria:

• FEV1/FVC < 70%

• FEV1 % predicted > 60%

Exclusion Criteria:

• Other major disease

• Asthma

• Currently taking inhaled corticosteroids

• oral corticosteroids in the last 3 month

• significant cardiovascular disease

• pregnancy/breast feeding

• current use of salmeterol or other long acting bronchodilator