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

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00893009
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Theophylline; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2009
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: Theophylline 100 twice a day	Drug: Theophylline; 100 mg twice a day

Outcome Measures

Primary Outcome Measures

1. Air trapping [1 year]

Secondary Outcome Measures

1. endurance time [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Heart failure Malignancy Immune suppressed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonar Institute, Assaf Harofeh Medical Center	Beer Yaakov		Israel	70300

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00893009
• Other Study ID Numbers: 02/09
• First Posted: May 5, 2009
• Last Update Posted: Apr 5, 2011
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: Forced expiratory volume in one second; Inspiratory capacity; endurance time; residual volume
• Additional relevant MeSH terms: Theophylline

Study Results

No Results Posted as of Apr 5, 2011