Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) (PPIPF)
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|ClinicalTrials.gov Identifier: NCT02085018|
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : November 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Omeprazole Drug: Matched placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)|
|Actual Study Start Date :||March 28, 2014|
|Actual Primary Completion Date :||September 27, 2016|
|Actual Study Completion Date :||September 27, 2016|
Omeprazole 20 milligrams twice a day taken for 90 days
Other Name: Losec
Placebo Comparator: Matched placebo
Matched placebo twice a day taken for 90 days
Drug: Matched placebo
- objectively measured cough frequency [ Time Frame: 90 days ]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.
- symptoms of cough [ Time Frame: 90 days ]change in symptoms of cough at the end of treatment as measured by validated cough questionnaire
- reflux symptoms [ Time Frame: 90 days ]change in symptoms of reflux as measured by validated questionnaires
- acid and non-acid reflux [ Time Frame: 90 days ]change in acid and non-acid reflux measured by oesophageal physiological study
- vital capacity (VC) & transfer factor for carbon monoxide (Tco) [ Time Frame: 90 days ]change in VC and Tco as measured by lung function tests
- 6 minute walk distance [ Time Frame: 90 days ]change in 6 minute walk distance from baseline to 90 days
- assess amount of inflammation in lung [ Time Frame: 90 days ]assess markers of lung inflammation in bronchoalveolar lavage (BAL) fluid (eg. concentration of transforming growth factor beta, interleukin-8 etc.)
- lung infection rate [ Time Frame: 90 days ]assess bronchoalveolar lavage (BAL) fluid for infections over period from baseline to 90 days, also patient reported infection in adverse event diary
- adverse events rate [ Time Frame: 90 days ]patient reported adverse events, assess lung infection rate in bronchoalveolar fluids over period from baseline to 90 days
- rate of recruitment [ Time Frame: 18 months ]Number of participants eligible and consented for study
- rate of study completion [ Time Frame: 18 months ]Number of participants completing all study procedures (over 90 days for each participant)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085018
|The Newcastle upon Tyne Hospitals NHS Foundation Trust|
|Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP|
|Study Director:||John Simpson, FRCP||Newcastle University|
|Principal Investigator:||Ian Forrest, MRCP||Newcastle upon Tyne Hospitals NHS Foundation Trust|