COPDNCT00671151
Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
A study testing Theophylline in people with COPD, run by Hospital Universitari Son Dureta at 1 site in Spain.
Trial summary
Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Theophylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2005to Dec 2007
- 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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe COPD according to GOLD guidelines
- Age between 40 and 75
- Admission to hospital due to COPD exacerbation
Who cannot join
- History of asthma
- Pulmonary embolism
- Pneumonia
- Other chronic inflammatory disease
- Patient on theophylline at the time of admission
- Patient on oral steroids at the time of admission
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline
Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. To correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess the effect of theophylline on previous molecular, functional and clinical data. Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and oxidative stress will be determined with specific assays. These determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function
- Conditions
- COPD
- Being tested
- Theophylline
- Keywords
- COPD exacerbation, histone, steroid resistance, inflammation, theophylline
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheophyllineDrug
Theophylline 100 mg bid for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low-dose theophylline on top of standard therapy for COPD exacerbation Receives: Drug: Theophylline |
| 2 | No intervention | Standard therapy for COPD exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDAC activity in alveolar macrophages
Measured: 3 months
Secondary outcomes (2)
Lung function
Measured: 3 months
Inflammatory cytokine release in sputum and serum
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJun 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigación Sanitaria (FIS), Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Borja G Cosio, MD, Principal investigator, Hospital Universitario Son Dureta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671151
- Sponsor's protocol ID
- FIS042146
- Status last verified
- Apr 2008
- First submitted
- 30 Apr 2008
- Last updated
- 5 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cosio BG, Tsaprouni L, Ito K, Jazrawi E, Adcock IM, Barnes PJ. Theophylline restores histone deacetylase activity and steroid responses in COPD macrophages. J Exp Med. 2004 Sep 6;200(5):689-95. doi: 10.1084/jem.20040416. Epub 2004 Aug 30.
PubMed 15337792Cosio BG, Iglesias A, Rios A, Noguera A, Sala E, Ito K, Barnes PJ, Agusti A. Low-dose theophylline enhances the anti-inflammatory effects of steroids during exacerbations of COPD. Thorax. 2009 May;64(5):424-9. doi: 10.1136/thx.2008.103432. Epub 2009 Jan 21.
PubMed 19158122
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline
- ClinicalTrials.gov ID
- NCT00671151
- Acronym / sponsor ID
- FIS042146
- Conditions
- COPD
- Keywords
- COPD exacerbation, histone, steroid resistance, inflammation, theophylline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Fondo de Investigación Sanitaria (FIS), Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Jun 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 May 2008 (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.
Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. To correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess the effect of theophylline on previous molecular, functional and clinical data. Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and oxidative stress will be determined with specific assays. These determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TheophyllineLow-dose theophylline on top of standard therapy for COPD exacerbation |
| 2 | No intervention | –Standard therapy for COPD exacerbation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe COPD according to GOLD guidelines
- Age between 40 and 75
- Admission to hospital due to COPD exacerbation
Key exclusion criteria (6 listed)
- History of asthma
- Pulmonary embolism
- Pneumonia
- Other chronic inflammatory disease
- Patient on theophylline at the time of admission
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 |
|---|---|---|
| TheophyllineTheophylline 100 mg bid for 3 months | Drug | 1 |
Primary outcome
HDAC activity in alveolar macrophages
Time frame: 3 months
2 secondary outcomes
Lung function
Time frame: 3 months
Inflammatory cytokine release in sputum and serum
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2008.
- Background: PubMed 15337792Cosio BG, Tsaprouni L, Ito K, Jazrawi E, Adcock IM, Barnes PJ. Theophylline restores histone deacetylase activity and steroid responses in COPD macrophages. J Exp Med. 2004 Sep 6;200(5):689-95. doi: 10.1084/jem.20040416. Epub 2004 Aug 30.
- Derived from this study: PubMed 19158122Cosio BG, Iglesias A, Rios A, Noguera A, Sala E, Ito K, Barnes PJ, Agusti A. Low-dose theophylline enhances the anti-inflammatory effects of steroids during exacerbations of COPD. Thorax. 2009 May;64(5):424-9. doi: 10.1136/thx.2008.103432. Epub 2009 Jan 21.
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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.
Borja G Cosio, MD principal investigator
Hospital Universitario Son Dureta
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 Hospital Universitari Son Dureta at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 May 2008. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDAC activity in alveolar macrophages (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671151, which also lists 2 linked publications.
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 May 2008.