Pilot trial of omeprazole in idiopathic pulmonary fibrosis
Research type
Research Study
Full title
A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF)
IRAS ID
131932
Contact name
John Simpson
Contact email
Sponsor organisation
Regent centre
Eudract number
2013-003301-26
ISRCTN Number
N/A
Research summary
Idiopathic pulmonary fibrosis (IPF) is a condition in which scar tissue forms in the lung for no apparent reason. IPF produces significant breathlessness and cough, and typically affects older patients. The average life expectancy after a diagnosis of IPF tends to be only 2.5-5 years, and unfortunately no drug treatments have impacted upon this figure. The only potential ’cure’ is a lung transplant, but the significant majority of patients with IPF do not satisfy criteria for transplantation. In the absence of good treatment, focus has turned to better treatment of the disabling symptoms of breathlessness and cough.
In recent years increasing evidence has suggested that ’reflux’ of fluid from the stomach may contribute to lung disease in IPF. The theory is that small amounts of stomach fluid reaching the top of the gullet may inadvertently (and repeatedly) “go down the wrong way“ and end up in the lungs. As stomach fluid is acidic, it may damage lung tissue, accelerating scar tissue formation.
This background has stimulated interest in whether medicines that switch off stomach acid might improve symptoms in IPF. We know that acid ’reflux’ causes cough. As cough is a frequent and disabling symptom in IPF, our pilot study seeks to test whether omeprazole (a medicine that switches off stomach acid) can reduce cough in patients with IPF.
The study is a randomised controlled trial, in which 30 patients will receive omeprazole and 30 will receive placebo for 3 months. Neither patients nor research staff will know whether omeprazole is being taken (ie the study is ’double-blinded’). Patients will be randomly assigned to whether they receive omeprazole or placebo. We shall measure cough objectively, before and near the end of treatment. We shall also measure lung function, symptoms of reflux, walking distance, and side effects of treatment.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0284
Date of REC Opinion
20 Sep 2013
REC opinion
Favourable Opinion