nderstanding breathlessness in interstitial lung disease

Not Applicable

Completed

• Conditions: Interstitial Lung Disease; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001018909
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Study Completion: 2021-08-02
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

•Patients with fibrotic ILD (total lung capacity <80% predicted; FEV1/FVC > 0.7 and standard HRCT criteria (British Thoracic Society guidelines, 2008)
•Control participants free from fibrotic ILD
•Men and women
•Aged 18 years or over

Exclusion Criteria

•More than 10 pack year smoking history
•Evidence of emphysema on CT scan
•Pulmonary Sarcoidosis
•Currently taking regular inhaled therapy for airways disease
•Serious co-morbidities that may contribute to dyspnoea and/or reduce exercise capacity including:
oSevere respiratory disease other than ILD (e.g., chronic obstructive pulmonary disease)
oPulmonary hypertension
oSevere obesity (Body mass index > 35 kg/m2)
oSevere orthopaedic impairment or rheumatologic disease
oSignificant neurological disease
oInfection or pyrexial illness

•Presence of any contraindications to cardiopulmonary exercise testing (as per American Thoracic Society/American College of Chest Physicians Statement on Cardiopulmonary Exercise Testing, 2003)
oUnstable angina or recent acute myocardial infarction
oUncontrolled arrhythmias causing symptoms or haemodynamic compromise
oSymptomatic severe aortic stenosis
oOxygen saturation <85% at rest on room air
oUncontrolled heart failure
oUncontrolled asthma
oUncontrolled thyroid disorders
oMental impairment leading to inability to cooperate

•Current pregnancy
•Current users of recreational drugs
•Current abusers of alcohol
•Inability to fully or appropriately provide consent (e.g., language issue, reading capability)
•Underlying medical conditions, which in the opinion of the Investigator place the participant at unacceptably high risk for participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dyspnoea intensity as assessed using Modified Borg Scale[standardised times<br>-For intervention trials this will be end of exercise period and end of cuff occlusion period<br>-For control trials this will be end of exercise period and middle of recovery period];Minute ventilation measured using an oronasal mask (Hans Rudolph) attached to a heated pneumotachograph[Breath-by-breath measurements during the trials (each trial will be 8 minutes in duration)]