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

NCT04524819 | Terminated

• 1 other identifier: PHT/2019/46
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with COPD

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum and Saliva

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: August 24, 2020
• Study Start: September 18, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)