Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough

  • STATUS
    Recruiting
  • End date
    Aug 21, 2022
  • participants needed
    44
  • sponsor
    Royal Brompton & Harefield NHS Foundation Trust
Updated on 21 March 2021

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 significant physical, social and psychological consequences particularly anxiety and depression.

The cause of cough in IPF is poorly understood and there are currently no proven effective therapies. Morphine has long been advocated for the suppression of chronic cough in other conditions. While morphine is frequently used as a palliative agent for breathlessness in IPF, its effects on cough have never been tested. The aim of this study is therefore to explore and compare the effect of low dose morphine, one of the few therapies shown to be effective in some patients with otherwise refractory chronic cough, in patients with IPF, to an inactive substance known as a placebo.

To make a fair comparison, patients will be randomly allocated to receiving either morphine or placebo in a blinded fashion. This means neither the doctor nor the patient will know which drug they are receiving, and the drugs will appear the same. However, the trial is designed so that you will receive both morphine and placebo, but at different times (this is called a cross-over study). More specifically, you will be given either morphine or placebo for 14 days at a time.

In this study, it is hypothesised that compared with placebo, low dose (5mg) controlled release Morphine sulfate (MST) will reduce the number of coughs recorded during a 24hr period in patients with IPF.

Details
Condition Pulmonary Fibrosis, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment morphine sulfate, Placebo Oral Tablet
Clinical Study IdentifierNCT04429516
SponsorRoyal Brompton & Harefield NHS Foundation Trust
Last Modified on21 March 2021

Eligibility

Yes No Not Sure

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
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