Status:
COMPLETED
Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause that results in scarring of the lungs. Cough is reported by 85% of patients with IPF and can be a distressing symptom with significan...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04429516
Start Date
December 17 2020
End Date
March 21 2023
Last Update
April 14 2023
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6NP