A System to Classify Treatable Traits in Primary Care

NCT05357274 | Unknown

• 1 other identifier: RC2021/01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes an approach to address an urgent unmet need in clinical practice, namely a pragmatic method of establishing what is the cause of a patient's complaint and the next steps to address this problem. In this study, the investigators will compare the proposed classification with current best practice of self-report, spirometry and FeNO. The investigators will compare the two approaches with a gold standard of deep characterisation by 3 separate diagnostic tests. The investigators hypothesize that patients with symptoms of respiratory disease fall into one of four working groups based on accurate knowledge of three parameters, airflow, treatment use and the patient's symptoms.

Conditions

Respiratory Disease; Asthma; Copd

Outcome Measures

Primary Outcomes (2)

• Comparing gold standard asthma diagnostics to PEFR (L/min)

  To assess the sensitivity of using serially measured, digital lung function measures (PEFR L/min) in confirming a diagnosis of asthma.

  12 weeks

• Comparing gold standard asthma diagnostics to repeated measures of lung function FEV1/FVC

  To assess the sensitivity of using serially measured, lung function FEV1/FVC in confirming a diagnosis of asthma.

  12 weeks

Secondary Outcomes (2)

• Diurnal variation

  12 weeks

• Activity levels

  12 weeks

Study Arms (1)

Respiratory

Patients attending primary care, non-specialist respiratory clinics and advanced nurse practitioner clinics with undiagnosed persisting respiratory symptoms that have been attributed to asthma by a physician.

Diagnostic Test: Diagnostic testing

Interventions

Diagnostic testing DIAGNOSTIC_TEST

Data will be uploaded to a server where algorithms will be deployed that incorporate features related to treatment use and variables of airflow will allocate the care pathway into one of the 4 pathways. Treatment will be directed by this using a validated automated decision support system

Respiratory

Eligibility Criteria

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

Study Population

Patients attending primary care, non-specialist respiratory clinics and advanced nurse practitioner clinics with undiagnosed persisting respiratory symptoms that have been attributed to asthma by a physician.

You may qualify if:

• Capable of understanding and willing to give voluntary informed consent prior to any protocol specific procedures being performed.
• Patients aged over 18 years.
• Present with persisting respiratory symptoms that are suggestive of airways disease.
• Capable of understanding and complying with the requirements of the protocol, including ability to attend for all 3 required visits.
• Able and willing to take inhaled medication via an Ellipta. \[In the opinion of the investigator suitable for use of this inhaler.\]
• Willing to use an electronic spirometer \& peak flow meter.
• Currently prescribed Inhaled Corticosteroids (ICS) either alone or in combination with long acting beta agonists (ICS/LABA)

You may not qualify if:

• Have an active laboratory confirmed diagnosis of Asthma or COPD (with change to treatment within the last 8 weeks).
• Known previous sensitivity to ICS and Beta Agonist.
• Known significant (in the opinion of the investigator) concurrent medical disease that might mean that the patient cannot complete the full study.
• Intercurrent respiratory tract infection requiring antibiotic treatment in the last week
• Acute exacerbation of symptoms in the last 14 days requiring oral corticosteroid treatment
• Currently on specific concurrent potent cytochrome P450 3A4 (CYP3A4) medications; ketoconazole and ritonavir.
• Pregnancy
• Have greater than a 20-Pack Year Smoking History

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

Related Publications (11)

• Board G. GINA Report, Global Strategy for Asthma Management and Prevention. GINA Report, Global Strategy for Asthma Management and Prevention. 2016.

  BACKGROUND

• McDonald VM, Clark VL, Cordova-Rivera L, Wark PAB, Baines KJ, Gibson PG. Targeting treatable traits in severe asthma: a randomised controlled trial. Eur Respir J. 2020 Mar 5;55(3):1901509. doi: 10.1183/13993003.01509-2019. Print 2020 Mar.

  PMID: 31806719 BACKGROUND

• Aaron SD, Boulet LP, Reddel HK, Gershon AS. Underdiagnosis and Overdiagnosis of Asthma. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1012-1020. doi: 10.1164/rccm.201804-0682CI.

  PMID: 29756989 BACKGROUND

• Heaney LG, Busby J, Bradding P, Chaudhuri R, Mansur AH, Niven R, Pavord ID, Lindsay JT, Costello RW; Medical Research Council UK Refractory Asthma Stratification Programme (RASP-UK). Remotely Monitored Therapy and Nitric Oxide Suppression Identifies Nonadherence in Severe Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):454-464. doi: 10.1164/rccm.201806-1182OC.

  PMID: 30339770 BACKGROUND

• Moran C, Doyle F, Sulaiman I, Bennett K, Greene G, Molloy GJ, Reilly RB, Costello RW, Mellon L. The INCATM (Inhaler Compliance AssessmentTM): A comparison with established measures of adherence. Psychol Health. 2017 Oct;32(10):1266-1287. doi: 10.1080/08870446.2017.1290243. Epub 2017 Feb 28.

  PMID: 28276739 BACKGROUND

• Sulaiman I, Seheult J, MacHale E, D'Arcy S, Boland F, McCrory K, Casey J, Bury G, Al-Alawi M, O'Dwyer S, Ryder SA, Reilly RB, Costello RW. Irregular and Ineffective: A Quantitative Observational Study of the Time and Technique of Inhaler Use. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):900-909.e2. doi: 10.1016/j.jaip.2016.07.009.

  PMID: 27587321 BACKGROUND

• Sulaiman I, Cushen B, Greene G, Seheult J, Seow D, Rawat F, MacHale E, Mokoka M, Moran CN, Sartini Bhreathnach A, MacHale P, Tappuni S, Deering B, Jackson M, McCarthy H, Mellon L, Doyle F, Boland F, Reilly RB, Costello RW. Objective Assessment of Adherence to Inhalers by Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 May 15;195(10):1333-1343. doi: 10.1164/rccm.201604-0733OC.

  PMID: 27409253 BACKGROUND

• Blakey JD, Bender BG, Dima AL, Weinman J, Safioti G, Costello RW. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J. 2018 Nov 22;52(5):1801147. doi: 10.1183/13993003.01147-2018. Print 2018 Nov.

  PMID: 30409819 BACKGROUND

• Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.

  PMID: 29301919 BACKGROUND

• O'Dwyer S, Greene G, MacHale E, Cushen B, Sulaiman I, Boland F, Bosnic-Anticevich S, Mokoka MC, Reilly RB, Taylor T, Ryder SA, Costello RW. Personalized Biofeedback on Inhaler Adherence and Technique by Community Pharmacists: A Cluster Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Feb;8(2):635-644. doi: 10.1016/j.jaip.2019.09.008. Epub 2019 Sep 27.

  PMID: 31568927 BACKGROUND

• Gill CM, Kerr PJ, Ottewill C, Brennan V, Doherty H, Smith O, MacHale E, Cushen B, Ryan D, Greene G, Costello RW. Digitally assessed home FEV1 to identify the cause of poorly controlled asthma: a protocol paper for a prospective replicate cohort study. BMJ Open Respir Res. 2025 Dec 25;12(1):e003696. doi: 10.1136/bmjresp-2025-003696.

  PMID: 41448794 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum - periostin

MeSH Terms

Conditions

Respiration Disorders; Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Richard Costello, Professor

  Royal College of Surgeons, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine Mac Hale

CONTACT

018093730; elainemachale@rcsi.com

Lorna Lombard

CONTACT

018093787; Lornalombard@rcsi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 2, 2022
• Study Start: May 16, 2022
• Primary Completion: May 16, 2024
• Study Completion: December 31, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

IE (1)