Chronic Obstructive Pulmonary DiseaseSILO2NCT02024737
SILO2 (Signal Intensity Lung washOut)
An observational study of Chronic Obstructive Pulmonary Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of disease and death worldwide, affecting those in both developed and developing countries. This imparts a massive burden of ill health, in turn imposing huge healthcare costs to society. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MRI lung imaging (not an intervention per se but the focus of the study)
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Sep 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from COPD clinics in Sheffield, the surrounding area and the nurse-led clinics running alongside them, by open advertisement, after pulmonary rehabilitation, and via invitation by their local GP. The target is to recruit 6 subjects within 4 months.
Who may be able to join
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of study related procedures.
- Current or exsmokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Clinical diagnosis of COPD with a post bronchodilator FEV1 30-80% of personal predicted, according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.
Who cannot join
- Patients with a contra-indication to MRI scanning: i.e. patients who are non MRI compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire used in clinical practice by the Unit of Academic Radiology, Royal Hallamshire Hospital, or who are unable to tolerate the MRI.
- Patients with renal conditions (as described in the Gd-DTPA (Gadovist) Summary of Product Characteristics) in which administration of Gd-DTPA MR vascular contrast agent would pose a risk.
- Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- long and short acting beta-2 agonists
- sympathomimetic amines
- lactose or any of the other excipients
Show all 21Show fewer
- Resting oxygen saturation of <90% on air as determined by pulse oximetry.
- Women of child bearing potential, not using effective methods of contraception.
- Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
- Inability to understand or comply with study procedures; including patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler Aerolyzer®) device.
- Significant pulmonary pathology other than COPD.
- Previous lung surgery.
- Patients taking oral theophyllines, PDE4 inhibitors or leukotriene antagonists, or on maintenance treatment with oral steroids.
- Patients who are participating in the active phase of a supervised pulmonary rehabilitation program.
- Patients with a history of long QT syndrome or whose QTc measured (Fridericia method) is prolonged (>450 ms for males and females) or a history of dysrhythmia other than established chronic atrial fibrillation.
- Subjects with unstable cardiac disease which in the opinion of the investigator exposes them to significant additional risk. .
- Heart failure which is either unstable or the predominant cause of the subject's dyspnea.
- Patients who, in the judgment of the investigator, had a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
- Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of study enrollment (whichever is longer).
- Patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler Aerolyzer®) device.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: A Pilot Study to Establish the Sensitivity of MR Imaging Markers to Changes in Regional Lung Function and Gas Washout in Patients With Mild-moderate COPD
Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of disease and death worldwide, affecting those in both developed and developing countries. This imparts a massive burden of ill health, in turn imposing huge healthcare costs to society.
For effective treatment of COPD (as opposed to providing short term relief) early disease must be targeted. The small airways of the lung (those less than 2mm) are the first affected in COPD, but current methods to assess their function are relatively insensitive. There is therefore a need for new, accurate methods for detection of small airway dysfunction with sensitivity to shortterm change and regional discrimination.
Read more
In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and patients with early stage COPD, we showed sensitivity to early changes in lung ventilation and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent sensitivity to regional lung ventilation and function make it an ideal imaging tool for the assessment of novel lung therapies for diseases of the small airways.
The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD.
In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed.
This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MRI lung imaging (not an intervention per se but the focus of the study)
- 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.
MRI lung imaging (not an intervention per se but the focus of the study)Other
The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD. In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed (the bronchodilator foradil is a non-investigative medicinal product as it is a medicine with a known effect which will be used to induce a known response).
This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Severe COPD | Patients with moderate to severe COPD, as defined by GOLD 2-3 (The GOLD classifications are the main method doctors use to describe the severity of COPD.
GOLD is short for the Global Initiative for Chronic Obstructive Lung Disease, a collaboration between the National Institutes of Health and the World Health Organization) Receives: Other: MRI lung imaging (not an intervention per se but the focus of the study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility
Measure of short-term reproducibility of MRI imaging
Measured: 48 hours
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility
Measure of long-term reproducibility of MRI imaging
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024737
- Sponsor's protocol ID
- STH17337
- Acronym
- SILO2
- Status last verified
- Sep 2019
- First submitted
- 27 Dec 2013
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Establish the Sensitivity of MR Imaging Markers to Changes in Regional Lung Function and Gas Washout in Patients With Mild-moderate COPD
- ClinicalTrials.gov ID
- NCT02024737
- Acronym / sponsor ID
- SILO2 / STH17337
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Dec 2013 (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 leading and still increasing cause of disease and death worldwide, affecting those in both developed and developing countries. This imparts a massive burden of ill health, in turn imposing huge healthcare costs to society.
For effective treatment of COPD (as opposed to providing short term relief) early disease must be targeted. The small airways of the lung (those less than 2mm) are the first affected in COPD, but current methods to assess their function are relatively insensitive. There is therefore a need for new, accurate methods for detection of small airway dysfunction with sensitivity to shortterm change and regional discrimination.
In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and patients with early stage COPD, we showed sensitivity to early changes in lung ventilation and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent sensitivity to regional lung ventilation and function make it an ideal imaging tool for the assessment of novel lung therapies for diseases of the small airways.
The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD.
In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed.
This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-Severe COPD | – | Other: MRI lung imaging (not an intervention per se but the focus of the study)Patients with moderate to severe COPD, as defined by GOLD 2-3 (The GOLD classifications are the main method doctors use to describe the severity of COPD. GOLD is short for the Global Initiative for Chronic Obstructive Lung Disease, a collaboration between the National Institutes of Health and the World Health Organization) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from COPD clinics in Sheffield, the surrounding area and the nurse-led clinics running alongside them, by open advertisement, after pulmonary rehabilitation, and via invitation by their local GP. The target is to recruit 6 subjects within 4 months.
Key inclusion criteria (3 listed)
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of study related procedures.
- Current or exsmokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Clinical diagnosis of COPD with a post bronchodilator FEV1 30-80% of personal predicted, according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.
Key exclusion criteria (21 listed)
- Patients with a contra-indication to MRI scanning: i.e. patients who are non MRI compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire used in clinical practice by the Unit of Academic Radiology, Royal Hallamshire Hospital, or who are unable to tolerate the MRI.
- Patients with renal conditions (as described in the Gd-DTPA (Gadovist) Summary of Product Characteristics) in which administration of Gd-DTPA MR vascular contrast agent would pose a risk.
- Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- Resting oxygen saturation of <90% on air as determined by pulse oximetry.
- Women of child bearing potential, not using effective methods of contraception.
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 |
|---|---|---|
| MRI lung imaging (not an intervention per se but the focus of the study)The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD. In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed (the bronchodilator foradil is a non-investigative medicinal product as it is a medicine with a known effect which will be used to induce a known response). This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD. | Other | Moderate-Severe COPD |
Primary outcome
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility
Time frame: 48 hours
Measure of short-term reproducibility of MRI imaging
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility
Time frame: 21 days
Measure of long-term reproducibility of MRI imaging
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 17 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 3 inclusion and 21 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 17 Sep 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.
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?
Reproducibilityof 3He and 129Xe MRI lung ventilation imaging as measured by Bland-Altman statistical analysis of reproducibility (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 17 Sep 2019.