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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)

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ClinicalTrials.gov Identifier: NCT00893009
Recruitment Status : Unknown
Verified April 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 5, 2009
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:

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
COPD Drug: Theophylline Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. endurance time [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893009


Contacts
Contact: david Stav, MD 972 89779024 dstav@asaf.health.gov.il

Locations
Israel
Pulmonar Institute, Assaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel, 70300
Contact: David Stav, MD       dstav@asaf.health.gov.il   
Contact: Dimitri Gorban, MD         
Sub-Investigator: Dimitri Gorban, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information

Responsible Party: David Stav MD, Pulmonary Institute
ClinicalTrials.gov Identifier: NCT00893009     History of Changes
Other Study ID Numbers: 02/09
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2009

Keywords provided by Assaf-Harofeh Medical Center:
Forced expiratory volume in one second
Inspiratory capacity
endurance time
residual volume

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents