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

COPD Clinical Trial

— COPD  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00893009
• Other study ID #: 02/09
• Status: Not yet recruiting
• Phase: N/A
• First received: May 4, 2009
• Last updated: April 4, 2011
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2009
• Source: Assaf-Harofeh Medical Center
• Contact: david Stav, MD
• Phone: 972 89779024
• Email: dstav[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Heart failure Malignancy Immune suppressed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Theophylline
100 mg twice a day
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Pulmonar Institute, Assaf Harofeh Medical Center	Beer Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air trapping		1 year	No
Secondary	endurance time		1 year	No