Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough

Inclusion criteria

• Self-reported cough (> 8 weeks), with cough VAS ≥ 30/100
• A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines, in line with hospital records.
• Age 3.1. Male and female participants aged ≥ 40 - 90 years at the time of signing informed consent
• Sex:

4.1 Male participants: A male participant must agree to use contraception as detailed in Appendix 2 of this protocol during the study and for at least 90 days after the follow-up visit, and refrain from donating sperm during this period 4.2 Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP)

• Meeting all of the following criteria during the screening period: FVC ≥ 45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, DLCO corrected for Hb ≥30% predicted of normal.
• The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator determined within 24 months of the study screening visit)
• Written informed consent.

Exclusion criteria

• Treatment with immunosuppressive therapy or antibiotics within last 4 weeks. A stable dose of corticosteroids equivalent to prednisolone of 10 mg per day or less, if used for an indication other than pulmonary disease will be permitted
• Current smoker
• History of alcohol and drug(s) addiction
• Regular use of sedative therapies
• Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
• Concurrent use of pirfenidone or Nintedanib, unless receiving a stable dose for at least 8 weeks prior to screening
• Use of ACE inhibitors
• Patients with co-existent conditions know to be associated with the development of fibrotic lung disease. This includes: connective tissue disease, (plural plaques, mesothelioma), granulomatous disease including sarcoidosis. Patient with auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms. Non-specific rises in auto antibodies e.g. rheumatoid factors, anti-nuclear antibody etc. will not be used to exclude individuals from the study.
• Significant other organ co-morbidity including hepatic or renal impairment and pulmonary hypertension (investigator determined).
• Significant coronary artery disease (myocardial infarction within 6 months or ongoing unstable angina within 4 weeks of screening visit) or congestive cardiac failure based on clinical examination
• Patients as significant risk of side effects, intolerance or allergy to morphine
• Pregnant and breastfeeding patients, or women or child-bearing potential, not using a reliable contraceptive method (see Appendix 2). A urine pregnancy test will be performed in females of child-bearing potential at the initial study visit.
• Unable to provide informed written consent
• Predicted life expectancy < 6 months
• Use of long-term oxygen therapy. Use of ambulatory oxygen will be permitted.
• Current or use of opiates within 14 days of the screening visit.