Chronic Obstructive Pulmonary DiseaseSPIT-DNCT04524819
A Pilot Study to Characterise Saliva and Sputum FTIR Spectral Profiles in Patients with COPD During Exacerbations and When Stable
An observational study of Chronic Obstructive Pulmonary Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will characterise saliva and sputum FTIR spectral profiles in patients with COPD, during exacerbations and stable disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2019to 31 Oct 2023
- 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: Participants with COPD
Who may be able to join
- Participants with a confirmed diagnosis of an exacerbation of COPD (aged ≥40 years), n=40 (20 participants recruited in phase 1 and 20 participants recruited in phase 2) who are able to spontaneously expectorates sputum during exacerbations and on at least 3 out of 7 days when well.
- Able to provide written informed consent
Who cannot join
- Participants with other significant respiratory disease that, in the opinion of the clinical investigator, is the major cause of their respiratory symptoms (e.g. pulmonary tuberculosis, allergic bronchopulmonary aspergillosis, pulmonary fibrosis).
- Participants with COPD whose deterioration in respiratory symptoms is not thought to be due to an exacerbation of their COPD (e.g. pneumonia*, pneumothorax, pulmonary embolus).
- A member of the research study medical team will review the participant's chest X-Ray (CXR) to exclude any pneumonia, defined by consolidation on CXR before they are recruited onto the study if a CXR has been taken. In participants who have not had a CXR, exclusion of pneumonia will be based on clinical assessment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
This study will characterise saliva and sputum FTIR spectral profiles in patients with COPD, during exacerbations and stable disease.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common and treatable condition that is characterised by predominately irreversible and progressive airflow limitation. COPD is a leading cause of morbidity and mortality worldwide and its prevalence is predicted to increase substantially in the coming decade1. In the United Kingdom (UK) alone, COPD affects an estimated 3 million people, with 1 million diagnosed and a further 2 million remaining undiagnosed2. Delays in an accurate diagnosis impacts on quality of life and healthcare resource utilisation. COPD is associated with a significant economic and social burden, with a single severe exacerbation requiring admission to hospital costing up to £1600, therefore having a major impact on NHS expenditure. COPD also has a personal burden, causing 24 million lost working days annually, costing the UK economy £3.8 billion3.
Importance is placed on early detection of exacerbations of COPD as delays in starting treatment are associated with increased exacerbation severity, emergency healthcare use, a higher mortality and a more rapid decline in lung function. There is therefore a recognised need for widely accessible, easy-to-use tools to aid in the early detection of COPD exacerbations.
Fourier Transform Infra-Red (FTIR) spectroscopy is an emerging field of medicine which has the potential to become established in the management of lung conditions. Previous studies4,5 have shown that sputum in patients with COPD analysed with infrared (IR) gave reproducible biological IR spectra with distinct signatures in 5 key regions, namely Amide A, two signatures in the Amide I region, Amide II and in glycoproteins. The additional information on the spectral profiles gathered in this study on saliva and sputum from patients with COPD, during both stable disease and exacerbations will help establish FTIR use in the management of these lung conditions.
This study will provide essential information in the development process of a hand held FTIR spectroscope. Phase 1 will establish the infrared spectrum required for the analysis of saliva and sputum, which will inform the design of the daisy chain device (a pre-prototype device) used in phase 2. Phase 2 will test this infrared spectrum in the pre-prototype daisy chain device with further saliva and sputum samples, before this spectrum is incorporated into the eventual hand-held FTIR spectroscope.
- Conditions
- Chronic Obstructive Pulmonary Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD participants | Saliva and Sputum will be collected from patients when they are unwell with a flare up of the COPS and when they are well |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity
measured using the GOLD refined ABCD Assessment Tool
Measured: within a 24 month period
Disease Control
measured using the COPD Assessment Tool
Measured: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
FEV1 forced expiratory volume-one second
Assessment of lung function using spirometry to measure lung airflow
Measured: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
FVC forced vital capacity
Assessment of lung function using spirometry to measure lung airflow
Measured: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
FEV1/FVC ratio
Assessment of lung function using spirometry to measure lung airflow
Measured: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Sputum Culture
FTIR wavelength
Measured: immediately during analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start18 Sep 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Airborne particles during data collection a risk during COVID-19
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 crossover
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524819
- Sponsor's protocol ID
- PHT/2019/46
- Acronym
- SPIT-D
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2020
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Characterise Saliva and Sputum FTIR Spectral Profiles in Patients with COPD During Exacerbations and When Stable
- ClinicalTrials.gov ID
- NCT04524819
- Acronym / sponsor ID
- SPIT-D / PHT/2019/46
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Airborne particles during data collection a risk during COVID-19
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Aug 2020 (actual)
- 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.
This study will characterise saliva and sputum FTIR spectral profiles in patients with COPD, during exacerbations and stable disease.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common and treatable condition that is characterised by predominately irreversible and progressive airflow limitation. COPD is a leading cause of morbidity and mortality worldwide and its prevalence is predicted to increase substantially in the coming decade1. In the United Kingdom (UK) alone, COPD affects an estimated 3 million people, with 1 million diagnosed and a further 2 million remaining undiagnosed2. Delays in an accurate diagnosis impacts on quality of life and healthcare resource utilisation. COPD is associated with a significant economic and social burden, with a single severe exacerbation requiring admission to hospital costing up to £1600, therefore having a major impact on NHS expenditure. COPD also has a personal burden, causing 24 million lost working days annually, costing the UK economy £3.8 billion3.
Importance is placed on early detection of exacerbations of COPD as delays in starting treatment are associated with increased exacerbation severity, emergency healthcare use, a higher mortality and a more rapid decline in lung function. There is therefore a recognised need for widely accessible, easy-to-use tools to aid in the early detection of COPD exacerbations.
Fourier Transform Infra-Red (FTIR) spectroscopy is an emerging field of medicine which has the potential to become established in the management of lung conditions. Previous studies4,5 have shown that sputum in patients with COPD analysed with infrared (IR) gave reproducible biological IR spectra with distinct signatures in 5 key regions, namely Amide A, two signatures in the Amide I region, Amide II and in glycoproteins. The additional information on the spectral profiles gathered in this study on saliva and sputum from patients with COPD, during both stable disease and exacerbations will help establish FTIR use in the management of these lung conditions.
This study will provide essential information in the development process of a hand held FTIR spectroscope. Phase 1 will establish the infrared spectrum required for the analysis of saliva and sputum, which will inform the design of the daisy chain device (a pre-prototype device) used in phase 2. Phase 2 will test this infrared spectrum in the pre-prototype daisy chain device with further saliva and sputum samples, before this spectrum is incorporated into the eventual hand-held FTIR spectroscope.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD participants | – | –Saliva and Sputum will be collected from patients when they are unwell with a flare up of the COPS and when they are well |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with COPD
Key inclusion criteria (2 listed)
- Participants with a confirmed diagnosis of an exacerbation of COPD (aged ≥40 years), n=40 (20 participants recruited in phase 1 and 20 participants recruited in phase 2) who are able to spontaneously expectorates sputum during exacerbations and on at least 3 out of 7 days when well.
- Able to provide written informed consent
Key exclusion criteria (3 listed)
- Participants with other significant respiratory disease that, in the opinion of the clinical investigator, is the major cause of their respiratory symptoms (e.g. pulmonary tuberculosis, allergic bronchopulmonary aspergillosis, pulmonary fibrosis).
- Participants with COPD whose deterioration in respiratory symptoms is not thought to be due to an exacerbation of their COPD (e.g. pneumonia*, pneumothorax, pulmonary embolus).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease severity
Time frame: within a 24 month period
measured using the GOLD refined ABCD Assessment Tool
Disease Control
Time frame: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
measured using the COPD Assessment Tool
FEV1 forced expiratory volume-one second
Time frame: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Assessment of lung function using spirometry to measure lung airflow
FVC forced vital capacity
Time frame: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Assessment of lung function using spirometry to measure lung airflow
FEV1/FVC ratio
Time frame: a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Assessment of lung function using spirometry to measure lung airflow
Sputum Culture
Time frame: immediately during analysis
FTIR wavelength
Results and safety
The study was stopped early (reason given: Airborne particles during data collection a risk during COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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 Portsmouth Hospitals NHS 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Nov 2024. 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 was stopped early (reason given: Airborne particles during data collection a risk during COVID-19). Results are not available in the source record.
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?
Disease severity (time frame: within a 24 month period). The study lists 6 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 8 Nov 2024.