COPDCOPDNCT00893009
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
A study testing Theophylline in people with COPD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Theophylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up
Who cannot join
- Heart failure Malignancy Immune suppressed
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonar Institute, Assaf Harofeh Medical Center
Beer Yaakov, 70300
David Stav, MD, dstav@asaf.health.gov.il
Dimitri Gorban, MD
About this study
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
- Being tested
- Theophylline, Placebo
- Keywords
- Forced expiratory volume in one second, Inspiratory capacity, endurance time, residual volume
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheophyllineDrug
100 mg twice a day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Theophylline | Active comparator | 100 twice a day Receives: Drug: Theophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air trapping
Measured: 1 year
Secondary outcomes (1)
endurance time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893009
- Sponsor's protocol ID
- 02/09
- Acronym
- COPD
- Status last verified
- Apr 2009
- First submitted
- 4 May 2009
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00893009
- Acronym / sponsor ID
- COPD / 02/09
- Conditions
- COPD
- Keywords
- Forced expiratory volume in one second, Inspiratory capacity, endurance time, residual volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Theophylline | Active comparator | Drug: Theophylline100 twice a day |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up
Key exclusion criteria (1 listed)
- Heart failure Malignancy Immune suppressed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theophylline100 mg twice a day | Drug | Theophylline |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Air trapping
Time frame: 1 year
1 secondary outcome
endurance time
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theophylline in people with COPD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact david Stav, MD (972 89779024, dstav@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air trapping (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.