Last updated: April 13, 2023
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Overall Status: Completed
Phase
3
Condition
Lung Disease
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Treatment
N/AClinical Study ID
NCT04429516
RBH2019/001
2019-003571-19
Ages 40-90 All Genders
Study Summary
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 applicableATS/ERS/JRS/ALAT guidelines, in line with hospital records.
- Age 3.1. Male and female participants aged ≥ 40 - 90 years at the time of signinginformed consent
- Sex: 4.1 Male participants: A male participant must agree to use contraception as detailedin Appendix 2 of this protocol during the study and for at least 90 days after thefollow-up visit, and refrain from donating sperm during this period 4.2 Femaleparticipants: 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% predictedof 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 mostrecent HRCT scan (investigator determined within 24 months of the study screeningvisit)
- Written informed consent.
Exclusion
Exclusion criteria:
- Treatment with immunosuppressive therapy or antibiotics within last 4 weeks. A stabledose of corticosteroids equivalent to prednisolone of 10 mg per day or less, if usedfor 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 screeningperiod.
- Concurrent use of pirfenidone or Nintedanib, unless receiving a stable dose for atleast 8 weeks prior to screening
- Use of ACE inhibitors
- Patients with co-existent conditions know to be associated with the development offibrotic lung disease. This includes: connective tissue disease, (plural plaques,mesothelioma), granulomatous disease including sarcoidosis. Patient with auto-immuneprofile considered diagnostic for a specific connective tissue disease will beexcluded, even in the absence of systemic symptoms. Non-specific rises in autoantibodies e.g. rheumatoid factors, anti-nuclear antibody etc. will not be used toexclude individuals from the study.
- Significant other organ co-morbidity including hepatic or renal impairment andpulmonary hypertension (investigator determined).
- Significant coronary artery disease (myocardial infarction within 6 months or ongoingunstable angina within 4 weeks of screening visit) or congestive cardiac failure basedon 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 areliable contraceptive method (see Appendix 2). A urine pregnancy test will beperformed 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.
Study Design
Total Participants: 44
Study Start date:
December 17, 2020
Estimated Completion Date:
March 21, 2023
Connect with a study center
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
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