Improving Outcome Measures For Adult CF ACT Trials

NCT02721498 | Completed DMC

• 1 other identifier: 2016CF001B
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials. Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF. Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit. Analysis will be based upon differences in outcome measures and in-between study days.

Conditions

Cystic Fibrosis

Keywords

Respiratory Physiotherapy; Airway clearance techniques; Outcome measures

Outcome Measures

Primary Outcomes (5)

• Change in Lung Clearance Index

  This is a technique which involves breathing quietly through a tube whilst wearing nose clips. The test measures harmless tracer gases which are breathed in and out and measured by a sensitive gas-detection system. The LCI is calculated based on how long it takes for the gas to be breathed out from the lungs, and it shows if there are areas within the lung that are working less efficiently than others, for example when areas of the lung are clogged with mucus.

  Immediately pre-intervention and immediately post-intervention

• Change in Forced Expiratory Volume in One Second

  A forced expiratory manoeuvre into a spirometer (value derived from 1 second blow)

  Immediately pre-intervention and immediately post-intervention

• Electronic Impedance Tomography

  This technique involves wearing a belt around the chest which has electrodes attached to it. Undetectable alternating electrical currents are then applied to the electrodes, which the participant will not be able to feel. The machine measures how easy or difficult it is for that current to travel through the lungs and any differences are calculated, giving a picture of the ventilation of the lung.

  During intervention

• Change in Impulse Oscillation System

  The Impulse Oscillation system is a non-invasive technique where the participant breathes normally through a mouthpiece whilst wearing a nose clip, into a machine which produces small pressure vibrations (oscillations). The machine measures these vibrations and any changes to them to give an idea of obstructions to the airways, for example any mucus clogging.

  Immediately pre-intervention and immediately post-intervention

• Sputum Wet Weight

  Amount of sputum expectorated will be measured in a pre-weighed pot

  During intervention and for 30 minutes post-intervention

Secondary Outcomes (6)

• Change in Forced Vital Capacity

  Immediately pre-intervention and immediately post-intervention

• Change in Forced Expiratory Flow at 25% of Forced Vital Capacity

  Immediately pre-intervention and immediately post-intervention

• Change in Forced Expiratory Flow at 50% of Forced Vital Capacity

  Immediately pre-intervention and immediately post-intervention

• Change in Forced Expiratory Flow at 75% of Forced Vital Capacity

  Immediately pre-intervention and immediately post-intervention

• Oxygen saturation measurements

  During interventions

Study Arms (2)

Visit A

ACTIVE COMPARATOR

Rest period for 30-60 minutes

Other: Rest period

Visit B

ACTIVE COMPARATOR

Airway clearance session utilising the Active Cycle of Breathing techniques (ACBT) supervised by a specialist physiotherapist for 30-60 minutes.

Procedure: Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)

Interventions

Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) PROCEDURE

An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing)

Visit B

Rest period OTHER

A 30-60 minute of resting

Visit A

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF (confirmed by standard criteria)
• Sixteen years of age or over
• Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)

You may not qualify if:

• Current infective exacerbation or reduction in lung function requiring therapeutic intervention
• Current moderate haemoptysis (greater than streaking in the sputum)
• Current dependency on positive pressure support with ACT
• Previous history of spontaneous rib fractures
• Pregnancy
• Inability to give consent for treatment or measurement
• Current participation in another interventional study
• Current dependency upon non-invasive ventilation
• Current dependency upon oxygen therapy

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

The Royal Brompton Hospital

London, Greater London, SW3 6NP, United Kingdom

Location

Related Publications (8)

• Kent L, Reix P, Innes JA, Zielen S, Le Bourgeois M, Braggion C, Lever S, Arets HG, Brownlee K, Bradley JM, Bayfield K, O'Neill K, Savi D, Bilton D, Lindblad A, Davies JC, Sermet I, De Boeck K; European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) Standardisation Committee. Lung clearance index: evidence for use in clinical trials in cystic fibrosis. J Cyst Fibros. 2014 Mar;13(2):123-38. doi: 10.1016/j.jcf.2013.09.005. Epub 2013 Dec 5.

  PMID: 24315208 BACKGROUND

• Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.

  PMID: 16412951 BACKGROUND

• Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010 Mar;65(3):196-200. doi: 10.1136/thx.2008.111492. Epub 2009 Aug 23.

  PMID: 19703826 BACKGROUND

• Pfleger A, Steinbacher M, Schwantzer G, Weinhandl E, Wagner M, Eber E. Short-term effects of physiotherapy on ventilation inhomogeneity in cystic fibrosis patients with a wide range of lung disease severity. J Cyst Fibros. 2015 Sep;14(5):627-31. doi: 10.1016/j.jcf.2014.12.017. Epub 2015 Jan 19.

  PMID: 25612899 BACKGROUND

• Wettstein M, Radlinger L, Riedel T. Effect of different breathing aids on ventilation distribution in adults with cystic fibrosis. PLoS One. 2014 Sep 15;9(9):e106591. doi: 10.1371/journal.pone.0106591. eCollection 2014.

  PMID: 25222606 BACKGROUND

• Horsley A. 2009. 'Non-Invasive Assessment of Ventilation Maldistribution in Lung Disease Using Multiple Breath Inert Gas Washouts', University of Edinburgh, UK

  BACKGROUND

• Hurt, K. 2013. 'Small Airways Assessment In Adult Cystic Fibrosis', Imperial College (National Heart and Lung Institute), UK

  BACKGROUND

• Stanford G, Davies JC, Usmani O, Banya W, Charman S, Jones M, Simmonds NJ, Bilton D. Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial. BMJ Open Respir Res. 2020 Oct;7(1):e000694. doi: 10.1136/bmjresp-2020-000694.

  PMID: 33020113 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Nicholas J Simmonds, MD(Res) FRCP

  The Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 29, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)