A Feasibility RCT of Aerobika Verses ACBT in People With COPD

NCT05548036 | Unknown

• 1 other identifier: 21/WA/0144
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common preventable and treatable respiratory condition. Its main symptoms include, breathlessness, cough and frequent chest infections. Many people with COPD struggle with excessive production of sputum, resulting in more hospital admissions and worse symptoms affecting quality of life. Guidelines suggest techniques to help clear sputum but there is not strong evidence behind these. In particular we don't know how effective cough clearance techniques are and indeed if any are better than others. This study will recruit people admitted to hospital with an exacerbation of COPD who have excessive sputum and randomise them to receive a hand-held airways clearance device or chest physiotherapy exercises. We will compare symptoms, quality of life, treatment burden and hospital admissions over the following year.

Conditions

COPD; Bronchiolitis

Keywords

airways clearance

Outcome Measures

Primary Outcomes (1)

• To test the null hypothesis there is no difference in Leister Cough Questionnaire between groups at 3 months

  LCQ is a validated cough questionnaire. It consists of a 19-part questionnaire with a Likert scale scoring system between 1-7 measurements of physical, psychological, and social domains.

  3 months

Secondary Outcomes (1)

• To test the null hypothesis there is no difference in CAT between groups at 3 months

  3 months

Study Arms (2)

OPEP

ACTIVE COMPARATOR

Oscillatory Positive Expiratory Pressure OPEP is a technique aimed at loosening and mobilising secretions it can be achieved by using a device (AerobikaTM). The device provides pulses of resistance as you exhale acting to open airways and shake secretions, enabling expectoration using a huff and cough technique. Key factors to consider when completing a treatment session are body position, users should be seated, with good posture, in a comfortable position.

Device: OPEP

ACBT

ACTIVE COMPARATOR

Active Cycle of Breathing Technique ACBT is a method of breathing performed in a cycle, used to help loosen and clear secretions from within the lungs (Panaligan et al., 2012). It consists of three different phases.

Device: OPEP

Interventions

OPEP DEVICE

OPEP (Aerobika (tm)

Also known as: ACBT

ACBT; OPEP

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to hospital (current inpatient) or recent exacerbation treated in the community within 14 days with systemic steroids and/or antibiotics
• Male or Female, aged 40-90 years
• A diagnosis of COPD
• Greater than 10 pack year history
• FEV1 /FVC Ratio \<0.70 at any time point in the last 5 years
• Regular sputum production (most days for at least 3 months)
• Prescribed optimal pharmacological treatment
• Able to provide informed consent
• CAT score \>15

You may not qualify if:

• Contraindications to OPEP, recent hemoptysis or pneumothorax
• Unable to use OPEP (manual dexterity)
• Unstable cardiac conditions in the opinion of the clinical team
• Life expectancy less than 12 months.

Sponsors & Collaborators

• Carwyn Bridges: lead
• Cardiff and Vale University Health Board: collaborator
• Trudell Medical International: collaborator
• Respiratory Innovation Wales: collaborator

Study Sites (1)

Mr Carwyn Bridges

Cardiff, Wales, cf64 2xx, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiolitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carwyn G Bridges, PI

CONTACT

02921826841; carwyn.bridges2@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomised at recruitment then due to the nature of the intervention masking is not viable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hon research fellow

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: September 10, 2021
• Primary Completion: August 16, 2023
• Study Completion: April 1, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)