The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists
Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: Theophylline (Drug); Placebo (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Assaf-Harofeh Medical Center Overall contact: david Stav, MD, Phone: 972 89779024, Email: dstav@asaf.health.gov.il
Summary
Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder
causing disability with an increasing burden to the patient, his family and to the health
services. Treatment of COPD patients depends on the stage of the disease. COPD responds
poorly to corticosteroids, in spite of inflammation is a major component in its
pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory
effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are
now being elucidated, particularly as the molecular basis for the anti-inflammatory effects
of corticosteroids is better understood (12). An important mechanism of corticosteroid
resistance in COPD, which is also linked to amplification of the inflammatory process, is a
reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major
changes are at the level of small airways. We will examine the effect of addition of
theophylline product to stable COPD patients treated with combined inhaler of inhaled
corticosteroids.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Air trapping
Secondary outcome: endurance time
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up
Exclusion Criteria:
- Heart failure Malignancy Immune suppressed
Locations and Contacts
david Stav, MD, Phone: 972 89779024, Email: dstav@asaf.health.gov.il
Pulmonar Institute, Assaf Harofeh Medical Center, Beer Yaakov 70300, Israel; Recruiting David Stav, MD, Email: dstav@asaf.health.gov.il Dimitri Gorban, MD Dimitri Gorban, MD, Sub-Investigator
Additional Information
Starting date: July 2009
Last updated: April 4, 2011
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