ACTRN12621000454875招募中4 期
nderstanding dyspnoea and exercise limitation in interstitial lung disease: the role of pulmonary afferents (sub-study 2)
niversity of Auckland0 个研究点目标入组 15 人开始时间: 2021年4月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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