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Improving Outcome Measures For Adult CF ACT Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721498
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) Other: Rest period Not Applicable

Detailed Description:

Research Question: Does the use of a new assessment tool box (Electronic Impedance Tomography (EIT), Lung Clearance Index (LCI), Impulse Oscillation System (IOS)) give results that are more sensitive to change for the effect of an airway clearance technique (ACT) (the Active Cycle of Breathing Techniques (ACBT)) while having low variability and good repeatability in stable adult patients with cystic fibrosis (CF) than the traditional gold standard outcome measures of forced expiratory volume in one second (FEV1) and sputum wet weight?

Hypothesis: The use of a new outcome assessment tool box will allow more sensitive information about the effects of ACTs in stable adult patients with CF than the current gold standard measures.

This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London. Participants will be their own controls. Each participant will attend the research facility for two visits. Prior to starting the study assessment session participants will be questioned to ensure they are in a stable state of their disease (characterised by symptoms and having had no treatment changes for 28 days prior to the visit). All participants will continue with the timing and prescribed dosing of all inhaled medications as directed prior to the study. Subjects will be their own controls. Subjects 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 the Active Cycle of Breathing Techniques (ACBT) supervised by a specialist physiotherapist in adult CF. The ACT session will last for thirty minutes minimum, to 60 minutes maximum until a consensus is reached between participant and physiotherapist that the participant's chest is clear.

Subjects will perform the 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 immediately 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 given for completion after the last OM test is completed on each study visit.

There are no planned follow up measurements for participants in this study design.

All usual medications will be permitted for this study. Attention will be paid to mucoactive drugs (Pulmozyme®, Mannitol®, Hypertonic saline) to ensure the same frequency and dosing of inhalations for both study visits.

Data will be analysed in 3 groups based upon disease severity. Analysis will be based upon differences in outcome measures and in-between study days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2021
Actual Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: Visit A
Rest period for 30-60 minutes
Other: Rest period
A 30-60 minute of resting

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




Primary Outcome Measures :
  1. Change in Lung Clearance Index [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    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.

  2. Change in Forced Expiratory Volume in One Second [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    A forced expiratory manoeuvre into a spirometer (value derived from 1 second blow)

  3. Electronic Impedance Tomography [ Time Frame: During intervention ]
    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.

  4. Change in Impulse Oscillation System [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    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.

  5. Sputum Wet Weight [ Time Frame: During intervention and for 30 minutes post-intervention ]
    Amount of sputum expectorated will be measured in a pre-weighed pot


Secondary Outcome Measures :
  1. Change in Forced Vital Capacity [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    A forced expiratory manoeuvre into a spirometer (value derived from full expiration)

  2. Change in Forced Expiratory Flow at 25% of Forced Vital Capacity [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    A forced expiratory manoeuvre into a spirometer (value derived from full expiration)

  3. Change in Forced Expiratory Flow at 50% of Forced Vital Capacity [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    A forced expiratory manoeuvre into a spirometer (value derived from full expiration)

  4. Change in Forced Expiratory Flow at 75% of Forced Vital Capacity [ Time Frame: Immediately pre-intervention and immediately post-intervention ]
    A forced expiratory manoeuvre into a spirometer (value derived from full expiration)

  5. Oxygen saturation measurements [ Time Frame: During interventions ]
    Completed via a finger probe connected to a pulse oximeter which will record saturations over the whole session.

  6. Patient feedback questionnaire [ Time Frame: Straight after the intervention ]
    A patient reported outcome investigating the opinions of participants on each of the OMs completed during the trial using open and Likert scale questions



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721498


Locations
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United Kingdom
The Royal Brompton Hospital
London, Greater London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Nicholas J Simmonds, MD(Res) FRCP The Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London
Publications:
Horsley A. 2009. 'Non-Invasive Assessment of Ventilation Maldistribution in Lung Disease Using Multiple Breath Inert Gas Washouts', University of Edinburgh, UK
Hurt, K. 2013. 'Small Airways Assessment In Adult Cystic Fibrosis', Imperial College (National Heart and Lung Institute), UK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02721498    
Other Study ID Numbers: 2016CF001B
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Respiratory Physiotherapy
Airway clearance techniques
Outcome measures
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases