Idiopathic Pulmonary FibrosisPhase 2PPIPFNCT02085018
Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Omeprazole in people with Idiopathic Pulmonary Fibrosis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2014to 27 Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne & Wear, NE1 4LP
About this study
Official title: A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Omeprazole, Matched placebo
- Keywords
- omeprazole, idiopathic pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Losec
Drug
Matched placeboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Experimental | Omeprazole 20 milligrams twice a day taken for 90 days Receives: Drug: Omeprazole |
| Matched placebo | Placebo comparator | Matched placebo twice a day taken for 90 days Receives: Drug: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (8)
symptoms of cough
change in symptoms of cough at the end of treatment as measured by validated cough questionnaire
Measured: 90 days
reflux symptoms
change in symptoms of reflux as measured by validated questionnaires
Measured: 90 days
acid and non-acid reflux
change in acid and non-acid reflux measured by oesophageal physiological study
Measured: 90 days
vital capacity (VC) & transfer factor for carbon monoxide (Tco)
change in VC and Tco as measured by lung function tests
Measured: 90 days
6 minute walk distance
change in 6 minute walk distance from baseline to 90 days
Measured: 90 days
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.)
Measured: 90 days
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
Measured: 90 days
adverse events rate
patient reported adverse events, assess lung infection rate in bronchoalveolar fluids over period from baseline to 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study start28 Mar 2014
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- John Simpson, FRCP, Study director, Newcastle UniversityIan Forrest, MRCP, Principal investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085018
- Sponsor's protocol ID
- IAFIPF001
- Other IDs
- 2013-003301-26, IPFPSG12-7, 13/YH/0284
- Acronym
- PPIPF
- Status last verified
- Nov 2017
- First submitted
- 9 Feb 2014
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02085018
- Acronym / sponsor ID
- PPIPF / IAFIPF001
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- omeprazole, idiopathic pulmonary fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Experimental | Drug: OmeprazoleOmeprazole 20 milligrams twice a day taken for 90 days |
| Matched placebo | Placebo comparator | Drug: Matched placeboMatched placebo twice a day taken for 90 days |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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].
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: LosecDrug | Drug | Omeprazole |
| Matched placeboMatched placebo | Drug | Matched placebo |
Primary outcome
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.
8 secondary outcomes
symptoms of cough
Time frame: 90 days
reflux symptoms
Time frame: 90 days
acid and non-acid reflux
Time frame: 90 days
vital capacity (VC) & transfer factor for carbon monoxide (Tco)
Time frame: 90 days
6 minute walk distance
Time frame: 90 days
assess amount of inflammation in lung
Time frame: 90 days
lung infection rate
Time frame: 90 days
adverse events rate
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Simpson, FRCP study director
Newcastle University
Ian Forrest, MRCP principal investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omeprazole in people with Idiopathic Pulmonary Fibrosis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objectively measured cough frequency (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.