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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00893009
Acronym
COPD
Enrollment
30
Registered
2009-05-05
Start date
2009-07-31
Completion date
2009-12-31
Last updated
2011-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

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

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.

Interventions

DRUGPlacebo

Placebo

DRUGTheophylline

100 mg twice a day

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Air trapping1 year

Secondary

MeasureTime frame
endurance time1 year

Countries

Israel

Contacts

Primary Contactdavid Stav, MD
dstav@asaf.health.gov.il972 89779024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026