Status:
COMPLETED
Theophylline in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Ontario Lung Association
Conditions:
COPD
Eligibility:
All Genders
40-90 years
Phase:
PHASE2
PHASE3
Brief 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 chr...
Detailed Description
Objective: The primary objectives of this study is to assess the effects of 4 weeks of theophylline therapy on exercise performance and lung function in patients with COPD already receiving combinati...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00299858
Start Date
October 1 2006
End Date
May 1 2010
Last Update
July 7 2017
Active Locations (1)
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1
Ottawa Hospital, General campus
Ottawa, Ontario, Canada, K1H 8L6