Theophylline in Chronic Obstructive Pulmonary Disease

NCT00299858 | Completed Phase 2

• 1 other identifier: 2006036-01H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 chronic obstructive pulmonary disease already receiving both tiotropium and a long-acting beta-agonist (salmeterol or formoterol).

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease; Theophylline; Exercise testing

Outcome Measures

Primary Outcomes (1)

• Exercise duration during constant load (75% maximum) exercise testing

  End of 4 week treatment period

Secondary Outcomes (1)

• Changes in spirometry (FEV1) Changes in lung volumes

  End of 4 week treatment period

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Patients will be given theophylline, titrated to optimal blood levels, for a period of 4 weeks.

Drug: Theophylline

Placebo group

PLACEBO COMPARATOR

Patients will receive placebo pills for a period of 4 weeks.

Drug: Theophylline

Interventions

Theophylline DRUG

Patients assigned to study group, will receive slow-release theophylline at a dose of 10 mg/kg, titrated to blood levels between 55-110 umol/L, for a period of 4 weeks. Patients assigned to placebo group will receive identical-appearing placebo tablets for the same period of time.

Placebo group; Study Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ontario Lung Association: collaborator

Study Sites (1)

Ottawa Hospital, General campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Voduc N, Alvarez GG, Amjadi K, Tessier C, Sabri E, Aaron SD. Effect of theophylline on exercise capacity in COPD patients treated with combination long-acting bronchodilator therapy: a pilot study. Int J Chron Obstruct Pulmon Dis. 2012;7:245-52. doi: 10.2147/COPD.S29990. Epub 2012 Mar 29.

  PMID: 22563244 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nha Voduc, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

CA (1)