A Pilot Study to Characterise Saliva and Sputum FTIR Spectral Profiles in Patients With COPD During Exacerbations and When Stable

Chronic Obstructive Pulmonary Disease Clinical Trial

— SPIT-D  

Official title:

A Pilot Study to Characterise Saliva and Sputum FTIR Spectral Profiles in Patients With COPD During Exacerbations and When Stable

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04524819
• Other study ID #: PHT/2019/46
• Status: Suspended
• Start date: September 18, 2019
• Est. completion date: September 18, 2023

Study information

• Verified date: April 2023
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will characterise saliva and sputum FTIR spectral profiles in patients with COPD, during exacerbations and stable disease.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease severity	measured using the GOLD refined ABCD Assessment Tool	within a 24 month period
Primary	Disease Control	measured using the COPD Assessment Tool	a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Primary	FEV1 forced expiratory volume-one second	Assessment of lung function using spirometry to measure lung airflow	a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Primary	FVC forced vital capacity	Assessment of lung function using spirometry to measure lung airflow	a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Primary	FEV1/FVC ratio	Assessment of lung function using spirometry to measure lung airflow	a change between the exacerbation visit and stable visit through study completion, an average of 2 years
Primary	Sputum Culture	FTIR wavelength	immediately during analysis