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

Not Applicable

• Conditions: COPD
• Interventions: Drug: Placebo; Drug: Theophylline

• Registration Number: NCT00893009
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Study Start: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Last Update Submitted: 2011-04-04
• Last Update Posted: 2011-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up

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Exclusion Criteria

• Heart failure Malignancy Immune suppressed

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Theophylline	Theophylline	100 twice a day

Primary Outcome Measures

Name	Time	Method
Air trapping	1 year

Secondary Outcome Measures

Name	Time	Method
endurance time	1 year

Trial Locations

Locations (1)

Pulmonar Institute, Assaf Harofeh Medical Center; 🇮🇱 Beer Yaakov, Israel