Idiopathic Pulmonary Fibrosis Clinical Trial
— PPIPFOfficial title:
A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
Verified date | November 2017 |
Source | Newcastle-upon-Tyne Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal
lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract
oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with
the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are
breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to
improve the death rate, or to significantly impact upon symptoms, in IPF.
In recent years it has been recognised that cough can be caused by small amounts of liquid
coming up from the stomach and "going down the wrong way" into the lungs, a process commonly
known as "reflux". As liquid in the stomach is usually acidic, patients' lungs may repeatedly
be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially
contribute to the debilitating cough found with the disease. However there are many potential
causes for cough in IPF.
Stomach acid can be efficiently "switched off" by drugs called "proton pump inhibitors", one
of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF,
omeprazole might be expected to reduce cough. The purpose of this study is therefore to test
whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be
randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the
doctor will be aware which treatment has been given, ie this is a randomised "double-blind",
placebo--controlled trial. Patients' cough frequency will be measured before and after
treatment and the change in cough frequency compared in those receiving omeprazole and those
receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range
of other measurements will be assessed such as the numbers of patients eligible to take part,
agreeing to randomisation and providing outcome data, patients' lung function, symptom
scores, the amount of reflux, and the amount of inflammation in the lungs.
Status | Completed |
Enrollment | 45 |
Est. completion date | September 27, 2016 |
Est. primary completion date | September 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - IPF is considered the most likely diagnosis by the Regional Interstitial Lung Disease Multidisciplinary Team meeting (ILD-MDT). - History of cough, with or without exertional dyspnoea. - High resolution computed tomography (HRCT) scan features of honeycombing in a predominantly basal subpleural distribution. - Bibasal crackles on auscultation. - Features of a restrictive ventilatory defect [vital capacity (VC) <90% predicted and/or diffusion factor for carbon monoxide (Tco) <90% predicted]. - Aged 40-85 years. - Patients taking short courses (eg. 2 months) of proton pump inhibitors (PPI) will be eligible once the treatment has been discontinued for a minimum of 1 month. Exclusion Criteria: - Known allergy to Omeprazole or other proton pump inhibitor. - Concomitant use of warfarin, diazepam, phenytoin, ketoconazole. - Concomitant use of a regular PPI, antacid, prokinetic or raft alginate during the trial period. - History of upper respiratory tract infection, lower respiratory tract infection or exacerbation of IPF in the 4 weeks before starting study drugs. - Active trial of treatment for IPF 9eg. prednisolone, pirfenidone, N-acetylcysteine) started in the 4 weeks before starting study drugs. - Documented history of hepatic cirrhosis. - Pregnancy or lactation. - ILD-MDT considers the most likely cause of he patient's ILD to be a condition other than IPF (eg. rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic hypersensitivity pneumonitis, sarcoidosis, etc.). - Concurrent enrolment in a trial of a Clinical Trial of Investigational Medicinal Product (CTIMP) for IPF. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | Tyne & Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | rate of recruitment | Number of participants eligible and consented for study | 18 months | |
Other | rate of study completion | Number of participants completing all study procedures (over 90 days for each participant) | 18 months | |
Primary | objectively measured cough frequency | the change in frequency of objectively measured cough from beginning of the study to the end of treatment (within 2 weeks of completion of treatment). This will be compared in the two groups. | 90 days | |
Secondary | symptoms of cough | change in symptoms of cough at the end of treatment as measured by validated cough questionnaire | 90 days | |
Secondary | reflux symptoms | change in symptoms of reflux as measured by validated questionnaires | 90 days | |
Secondary | acid and non-acid reflux | change in acid and non-acid reflux measured by oesophageal physiological study | 90 days | |
Secondary | vital capacity (VC) & transfer factor for carbon monoxide (Tco) | change in VC and Tco as measured by lung function tests | 90 days | |
Secondary | 6 minute walk distance | change in 6 minute walk distance from baseline to 90 days | 90 days | |
Secondary | assess amount of inflammation in lung | assess markers of lung inflammation in bronchoalveolar lavage (BAL) fluid (eg. concentration of transforming growth factor beta, interleukin-8 etc.) | 90 days | |
Secondary | lung infection rate | assess bronchoalveolar lavage (BAL) fluid for infections over period from baseline to 90 days, also patient reported infection in adverse event diary | 90 days | |
Secondary | adverse events rate | patient reported adverse events, assess lung infection rate in bronchoalveolar fluids over period from baseline to 90 days | 90 days |
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