Patients with lung disease (COPD, interstitial pulmonary fibrosis, pulmonary hypertension) who require ambulatory oxygen because of exertional desaturation and adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/07/2023: 1. Adult patients with GOLD I-IV COPD who require ambulatory oxygen because of exertional desaturation 2. Adult patients with IPF who require ambulatory oxygen because of exertional desaturation 3. Adult patients with pulmonary hypertension who require ambulatory oxygen because of exertional desaturation 4. Adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities (abnormal gas transfer defined as a TLco <lower limit of normal) _____ Previous inclusion criteria as of 11/01/2023: 1. Adult patients with GOLD I-IV COPD who require ambulatory oxygen because of exertional desaturation 2. Adult patients with IPF who require ambulatory oxygen because of exertional desaturation 3. Adult patients with pulmonary hypertension who require ambulatory oxygen because of exertional desaturation 4. Adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities _____ Previous inclusion criteria: 1. Adult patients with GOLD I-IV COPD who require ambulatory oxygen because of exertional desaturation 2. Adult patients with IPF who require ambulatory oxygen because of exertional desaturation 3. Adult patients with pulmonary hypertension who require ambulatory oxygen because of exertional desaturation
Exclusion criteria
Exclusion criteria: 1. Clinically unstable patients (within one month of exacerbation) 2. Significant comorbidity limiting exercise tolerance 3. Significant renal impairment (estimated glomerular filtration rate (eGFR) <50 ml.min-1) 4. Hypotension (systolic blood pressure <100 mmHg) 5. Pregnancy 6. Use of nitrate based medication or PDE5 inhibitors such as sildenafil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An increase in endurance shuttle walk (ESWT) time breathing oxygen at the patient's customary flow rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Area under oxygen saturation curve to isotime during ESWT 2. Area under heart rate curve to isotime during ESWT 3. Resting blood pressure 4. Blood nitrate levels | — |
Countries
England, United Kingdom