Theophylline in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a prospective randomized double-blinded parallel group clinical trial evaluating the short-term effects of theophylline therapy on exercise duration and lung function in patients with chronic obstructive pulmonary disease already receiving both tiotropium and a long-acting beta-agonist (salmeterol or formoterol).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Ontario Lung Association
• Treatments: Theophylline

Criteria

Inclusion Criteria:

clinical diagnosis of COPD, that is at least "moderate" in severity according to GOLD guidelines (FEV1 60% predicted and FEV1/FVC ratio 70%).

clinically stable (no exacerbations nor changes in medications over the previous two months.

taking tiotropium 18ug qd and either salmeterol 50ug bid or formoterol 12 ug bid (the use of inhaled corticosteroids is not required but is permitted as long as there have been no dose changes over the last 2 months).

Exclusion Criteria:

Lung disease other than COPD (e.g: asthma, interstitial lung disease)

Non-pulmonary comorbidity that may potentially limit exercise capacity (e.g: cardiac disease, arthritis) or be exacerbated by theophylline use.

History of adverse response to theophylline or condition that may increase likelihood of adverse reaction with theophylline (cardiac disease, liver disease, renal impairment, thyroid disease)

Use of theophylline over last two months.

Use of a medication that may potentially interact with theophylline (e.g. warfarin, digoxin)

Patients currently enrolled (or scheduled to be enrolled) in a pulmonary rehabilitation program will not be accepted until after completion of the program (as this may potentially affect exercise performance).

Use of systemic corticosteroid therapy (this may affect peripheral muscle function)