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

NCT ID: NCT00893009

Last Updated: 2011-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Theophylline

100 twice a day

Group Type: ACTIVE_COMPARATOR

Theophylline

Intervention Type: DRUG

100 mg twice a day

Interventions

Theophylline

100 mg twice a day

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Heart failure Malignancy Immune suppressed

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pulmonary Institute

Locations

Pulmonar Institute, Assaf Harofeh Medical Center

Beer Yaakov, , Israel

Countries

Israel

Central Contacts

david Stav, MD

Role: CONTACT

dstav@asaf.health.gov.il

972 89779024

Facility Contacts

David Stav, MD

Role: primary

dstav@asaf.health.gov.il

Dimitri Gorban, MD

Role: backup

Other Identifiers

02/09

Identifier Type: -

Identifier Source: org_study_id