Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT00291408
Effect of Symbicort on HAT and HDAC in Sputum Macrophages of COPD
A Phase 4 study testing Skin Prick Test, Impulse Oscillometry and Exhaled Nitric Oxide in people with Chronic Obstructive Pulmonary Disease (COPD) and Age Matched Healthy Volunteers (Non-smokers), run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)
- What is being tested?
- Skin Prick Test, Impulse Oscillometry and Exhaled Nitric Oxide
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2006to Jun 2007
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking volunteer
- aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
- Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
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- aged 40 -75 years
- FEV1 greater than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value)
- FEV1/FVC < 70%
- Patients with stable COPD
- Inhaled Corticosteroid (ICS) treatment, if exists, must be stopped for 2 weeks prior the study treatment
- Long-acting beta2-agonists and theophylline need to be stopped at least 3 days before run-in , but anti-cholinergics will be allowed throughout the study
- The subjects are able to give informed consent
Who cannot join
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Evidence of asthma
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- Bronchodilator reversibility > 12%
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Patients who have had oral steroids within 8 weeks prior to the screening visit.
- Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period.
- Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit.
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patients with significant co-morbidities as judged by the investigator
- Any other respiratory disease, which is considered by the investigator to be clinically significant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Effect of Symbicort® and Pulmicort® on HAT and HDAC Expression and Activity in Induced Sputum Cells Obtained From COPD Patients.
The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)
- Being tested
- Skin Prick Test, Impulse Oscillometry, Exhaled Nitric Oxide, Spirometry, Reversibility
- 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.
Skin Prick TestProcedure or surgery
Impulse OscillometryProcedure or surgery
Exhaled Nitric OxideProcedure or surgery
SpirometryProcedure or surgery
ReversibilityProcedure or surgery
Exhaled Breath CondensateProcedure or surgery
Sputum InductionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
HDAC and HAT activity ratio
Secondary outcomes (1)
Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Researchers left the institute
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Peter J Barnes, MA DM DSc FRCP, Principal investigator, Imperial College LondonKazuhiro Ito, PhD, Principal investigator, Imperial College LondonIan Adcock, PhD, Principal investigator, Imperial College LondonSergei A Kharitonov, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291408
- Sponsor's protocol ID
- 05/Q0403/171
- Other IDs
- EudraCT Number: 2005-003297-13
- Status last verified
- Aug 2019
- First submitted
- 13 Feb 2006
- Last updated
- 7 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Effect of Symbicort® and Pulmicort® on HAT and HDAC Expression and Activity in Induced Sputum Cells Obtained From COPD Patients.
- ClinicalTrials.gov ID
- NCT00291408
- Acronym / sponsor ID
- 05/Q0403/171
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Age Matched Healthy Volunteers (Non-smokers)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researchers left the institute
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Feb 2006 (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.
The purpose of the study is to compare histone acetyltransferase (HAT) and histone deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from patients with moderate to severe COPD and age-matched normal non-smokers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Non-smoking volunteer
- aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
- Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines)
Key exclusion criteria (17 listed)
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
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 |
|---|---|---|
| Skin Prick Test | Procedure or surgery | – |
| Impulse Oscillometry | Procedure or surgery | – |
| Exhaled Nitric Oxide | Procedure or surgery | – |
| Spirometry | Procedure or surgery | – |
| Reversibility | Procedure or surgery | – |
| Exhaled Breath Condensate | Procedure or surgery | – |
| Sputum Induction | Procedure or surgery | – |
Primary outcome
HDAC and HAT activity ratio
1 secondary outcome
Several inflammation and anti-inflammation markers and lung function will be evaluted as shown below.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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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.
Peter J Barnes, MA DM DSc FRCP principal investigator
Imperial College London
Kazuhiro Ito, PhD principal investigator
Imperial College London
Ian Adcock, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin Prick Test, Impulse Oscillometry and Exhaled Nitric Oxide in people with Chronic Obstructive Pulmonary Disease (COPD) and Age Matched Healthy Volunteers (Non-smokers), run by Imperial College London at 1 site in United Kingdom.
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 13 inclusion and 17 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: withdrawn, as of the sponsor's last update on 7 Aug 2019. 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 and HAT activity ratio. 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 7 Aug 2019.