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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


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


Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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