A Pilot Study to Characterise Saliva and Sputum FTIR Spectral Profiles in Patients With COPD During Exacerbations and When Stable (SPIT-D)

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

Study Overview

• Status: Suspended
• Conditions: Chronic Obstructive Pulmonary 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants with COPD

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease severity	measured using the GOLD refined ABCD Assessment Tool	within a 24 month period
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
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
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
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
Sputum Culture	FTIR wavelength	immediately during analysis

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Anticipated): September 18, 2023
• Study Completion (Anticipated): September 18, 2023

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PHT/2019/46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No