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

NCT00893009 | Unknown

• 1 other identifier: 02/09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Forced expiratory volume in one second; Inspiratory capacity; endurance time; residual volume

Outcome Measures

Primary Outcomes (1)

• Air trapping

  1 year

Secondary Outcomes (1)

• endurance time

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Theophylline

ACTIVE COMPARATOR

100 twice a day

Drug: Theophylline

Interventions

Theophylline DRUG

100 mg twice a day

Theophylline

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Heart failure Malignancy Immune suppressed

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Pulmonar Institute, Assaf Harofeh Medical Center

Beer Yaakov, 70300, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

david Stav, MD

CONTACT

972 89779024; dstav@asaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 5, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 5, 2011

Record last verified: 2009-04

Locations

IL (1)