Investigating outcome measures for trials of airway clearance techniques in adults with cystic fibrosis

Not Applicable

Completed

• Conditions: Cystic fibrosis; Respiratory

• Registration Number: ISRCTN11220163
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33020113/ protocol (added 08/10/2020) 2022 Abstract results in https://doi.org/10.1016/S1569-1993(22)00848-7 Presented at North American Cystic Fibrosis Conference (added 01/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-19
• Study Completion: 2021-10-31
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Diagnosis of Cystic Fibrosis (confirmed by standard criteria)
2. Aged 16 years or over
3. Registered as patients of the Royal Brompton Hospital

Exclusion Criteria

1. Evidence of pulmonary exacerbation within 3 weeks prior to screening
2. Any change in a chronic treatment/prophylaxis regimen for CF or CF-related condition within 4 weeks of visit Current infective exacerbation or reduction in lung function requiring therapeutic intervention
3. Current moderate haemoptysis (greater than streaking in the sputum)
4. Current dependency on positive pressure support with ACT Previous history of spontaneous rib fractures
5. Pregnancy Inability to give consent for treatment or measurement
6. Current dependency upon non-invasive ventilation Current dependency upon oxygen therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Forced expiratory volume in 1 second (FEV1) is measured using spirometry immediately before and after the trial condition on each study visit<br>2. Lung clearance index (LCI) is measured using a multiple breath washout test immediately before and after the trial condition on each study visit<br>3. Impulse Oscillometry (IOS) is measured by a relaxed breathing test immediately before and after the trial condition on each study visit<br>4. Sputum weight is measured by weighing the amount of sputum expectorated during the treatment session immediately after the trial condition on each study visit<br>5. Electronic impedance tomography is measured during the treatment via an electrode belt around the chest, with measurements before, after and during the trial condition on each study visit

Secondary Outcome Measures

Name	Time	Method
1. Patient opinion of the outcome measure tests are measured using a questionnaire designed for the purpose of this study at the end of each study visit<br>2. Lung function tests (FVC, FEF 25, FEF 50, FEF 75) are completed using a spirometer before and after the trial condition in each study visit<br>3. Oxygen saturation is measured via a finger probe during the trial condition on each study visit