nderstanding breathlessness in interstitial lung disease

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• More than 10 pack year smoking history
• Evidence of significant 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:
o Severe respiratory disease other than ILD (e.g., chronic obstructive pulmonary disease)
o Pulmonary hypertension
o Severe obesity (Body mass index > 35 kg/m2)
o Severe orthopaedic impairment or rheumatologic disease
o Significant neurological disease
o Infection or pyrexial illness

• Presence of any contraindications to cardiopulmonary exercise testing
o Unstable angina or recent acute myocardial infarction
o Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
o Symptomatic severe aortic stenosis
o Oxygen saturation <85% at rest on room air
o Uncontrolled heart failure
o Uncontrolled asthma
o Uncontrolled thyroid disorders
o Mental impairment leading to inability to cooperate

• Current pregnancy
• Allergy or intolerance to fentanyl
• Use of anti-depressants (i.e monoamine oxidase inhibitors, serotonin reuptake inhibitors, serotonin norephinephrine re-uptake inhibitors) in the last 14 days
• Use of opioid medications (eg morphine, fentanyl, oxycodone, hydromorphone, methadone, codeine) in the previous 4 weeks.
• 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[ At the end of exercise (estimated to be <12 minutes)];Exercise endurance time measured using a timer on the cardiopulmonary exercise software[ At the end of the exercise (estimated to be <12 minutes)];Minute ventilation measured using an oronasal mask (Hans Rudolph) attached to a heated pneumotachograph[ breath-by-breath measurements during the cycle exercise (estimated to be <12 minutes)]

Secondary Outcome Measures

Name	Time	Method
Perceived rating of exertion using the Borg CR10 Rating of perceived exertion scale[ At the end of the exercise (estimated to be <12 minutes)];Heart rate measured using an electrocardiogram (12-lead)[ beat-by-beat measurements during exercise (estimated to be <12 minutes)];oxyhaemoglobin saturation using finger oximeter[ continuous measurements during exercise (estimated to be <12 minutes)];Blood pressure using an automated sphygmomanometer (cuff wrapped around upper arm) validated for use during exercise (SunTech)[ During last 45s of each 2 minute stage during exercise.];Oxygen consumption measured through gas analyser line attached to oronasal mask[ Breath by breath measurement during exercise (estimated to be <12 minutes)];CO2 production measured through gas analyser line attached to oronasal mask[ Breath-by-breath measurement during exercise (estimated to be <12 minutes)]

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