Idiopathic Pulmonary FibrosisPhase 2NCT02048644
Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary Fibrosis
A Phase 2 study testing fostair in people with Idiopathic Pulmonary Fibrosis, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The investigator has recently studied markers of platelet activation in idiopathic pulmonary fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet reactivity when compared with controls which is demonstrated by a concentration dependent increase in platelet-monocyte complex… 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?
- fostair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to May 2015
- 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
- Male or female subjects from 40 to 85 years of age
- Diagnosis of definite IPF according to American Thoracic Society / European respiratory symposium (ATS/ERS) Consensus Statement (2011) using either High-resolution computed tomography (HRCT) or surgical lung biopsy (SLB).
- Carbon monoxide transfer factor (TLco) of ≥ 30 % predicted ( historical measure accepted as long as within the last year).
- Able to maintain O2 saturation of ≥ 89% while breathing room air at rest.
- forced vital capacity (FVC) of 50-80% predicted value
- Negative serum pregnancy test at screening and negative urine pregnancy test at randomisation for female subjects of childbearing potential.
- Competency to understand the information given in the Ethics Committee approved Patient Information Sheet and Consent Form; subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed as standard of care for this disease
Who cannot join
- . Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.
- Clinically significant heart disease defined as a myocardial infarction documented by an ST elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening, percutaneous coronary intervention or coronary artery bypass surgery within 6 months prior to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV or known left ventricular ejection fraction < 25%), ischaemic heart disease, right heart failure, significant right ventricular hypertrophy, or uncontrolled arrhythmia.
- Current smokers
- Use of any inhaled long acting beta-agonist or inhaled steroid within the 3 months prior to screening
- Use of any medication to treat or possibly indicated in the treatment of IPF, such as pirfenidone, and oral corticosteroids.
- Use of any Antiplatelet therapy which may alter assessment of study end points e.g. clopidogrel, Prasugrel, Dipyridamole etc.
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- History of cancer, precancerous state (eg, familial polyposis, breast cancer 1 (BRCA1),breast cancer 2 (BRCA2), carcinoma in-situ), other than non-melanomatous skin cancer, within 5 years prior to screening.
- History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
- Participation in an investigational drug or device trial < 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Medicine Clinical trials Unit
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary Fibrosis
The investigator has recently studied markers of platelet activation in idiopathic pulmonary fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet reactivity when compared with controls which is demonstrated by a concentration dependent increase in platelet-monocyte complex formation, platelet P-selectin expression and platelet fibrinogen binding in the presence of' the platelet agonists Adenosine diphosphate and L- Threonyl- L- phenylalanyl- L- leucyl- L- leucyl- L-argininamide (TFLLR).
During platelet activation the platelets degranulate releasing numerous profibrotic cytokines including Transforming growth factor beta and Platelet derived growth factor that are recognised to be important in the pathogenesis of IPF. It is therefore plausible that the observed increased platelet reactivity in IPF contributes to the fibrotic process through local activation and degranulation with release of proinflammatory and profibrotic mediators within the pulmonary circulation.
Read more
There is evidence that corticosteroid treatment may alter platelet adhesion, in a study of spontaneously hypertensive rat (SHR) increased circulating glucocorticoid, suppressed p-selectin expression. p selectin is a transmembrane protein present in the α granules of platelets. P selectin has a crucial role in platelet aggregation and platelet-leukocyte interactions, which are both potentially important mechanisms in the initiation and/or progression of tissue injury and development of thrombosis. In a study of patients with chronic obstructive pulmonary disease (COPD) exacerbation these were treated with either β agonists alone or β agonist and 40mg prednisolone and compared with a control group. At presentation the COPD patients had higher pulmonary artery pressure (PAP) higher p selectin and fibrinogen levels but lower Antithrombin III levels (AT III). The pulmonary artery pressure and fibrinogen levels were found to be significantly decreased in the steroid treated group whilst the p-selectin levels further increased in the non steroidal therapy patients.
Rationale for the Current Study
There is a significant unmet medical need for the treatment of IPF; the only medication approved for treatment of IPF in the United Kingdom (UK) is Pirfenidone and outside the UK there is none. The main goal of the current study is to evaluate the effect of Fostair on the biomarkers of platelet activation in IPF disease which the investigator believes play a pivotal role in the pathogenesis of IPF and whether this translates in to a clinically beneficial effect of Fostair on IPF disease.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- fostair, placebo
- Keywords
- Platelets adhesion
- 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.
fostairDrug
Also called beclometasone dipropionate and formoterol fumarate
beclometasone dipropionate 200mcg and formoterol 12 mcg delivered by inhaler, twice a day for 28 days
placeboDrug
placebo matched inhaler 2puffs to be taken twice a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| placebo inhaler | Placebo comparator | matched placebo inhaler, to be taken 2 puffs, twice a day for 28 days Receives: Drug: placebo |
| fostair | Experimental | fostair 100mcg/6mcg 2pufss, twice a day. Receives: Drug: fostair |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet-monocyte complex formation
Measurements will include platelet-monocyte complex formation measured at baseline, and post investigational treatments at Visit 5 and visit 8.
Measured: 1 month
platelet P-selectin expression
platelet p selectin expression will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
Measured: 1 month
platelet fibrinogen binding
Platelet fibrinogen binding will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
Measured: 1 month
Secondary outcomes (3)
forced vital capacity
forced vital capacity will be measured at baseline and then at visit 5 and visit 8 following 1 months treatment of fostair or placebo
Measured: visit1, visit 5 and visit 8
sputum eosinophils cells
inflammatory cells will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
Measured: 1 month
six minute walk distance
six minute walk distance will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
- Investigators
- Simon Hart, MD, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048644
- Sponsor's protocol ID
- Acadmed18013
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2014
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright C, Arnell K, Fraser S, et al. S46 An RCT of 28 day treatment with Fostair® pMDI 200/12 BD on platelet biomarkers in patients with Idiopathic Pulmonary Fibrosis. Thorax 2015;70:A29-A30.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02048644
- Acronym / sponsor ID
- Acadmed18013
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Platelets adhesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Jan 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.
The investigator has recently studied markers of platelet activation in idiopathic pulmonary fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet reactivity when compared with controls which is demonstrated by a concentration dependent increase in platelet-monocyte complex formation, platelet P-selectin expression and platelet fibrinogen binding in the presence of' the platelet agonists Adenosine diphosphate and L- Threonyl- L- phenylalanyl- L- leucyl- L- leucyl- L-argininamide (TFLLR).
During platelet activation the platelets degranulate releasing numerous profibrotic cytokines including Transforming growth factor beta and Platelet derived growth factor that are recognised to be important in the pathogenesis of IPF. It is therefore plausible that the observed increased platelet reactivity in IPF contributes to the fibrotic process through local activation and degranulation with release of proinflammatory and profibrotic mediators within the pulmonary circulation.
There is evidence that corticosteroid treatment may alter platelet adhesion, in a study of spontaneously hypertensive rat (SHR) increased circulating glucocorticoid, suppressed p-selectin expression. p selectin is a transmembrane protein present in the α granules of platelets. P selectin has a crucial role in platelet aggregation and platelet-leukocyte interactions, which are both potentially important mechanisms in the initiation and/or progression of tissue injury and development of thrombosis. In a study of patients with chronic obstructive pulmonary disease (COPD) exacerbation these were treated with either β agonists alone or β agonist and 40mg prednisolone and compared with a control group. At presentation the COPD patients had higher pulmonary artery pressure (PAP) higher p selectin and fibrinogen levels but lower Antithrombin III levels (AT III). The pulmonary artery pressure and fibrinogen levels were found to be significantly decreased in the steroid treated group whilst the p-selectin levels further increased in the non steroidal therapy patients.
Rationale for the Current Study
There is a significant unmet medical need for the treatment of IPF; the only medication approved for treatment of IPF in the United Kingdom (UK) is Pirfenidone and outside the UK there is none. The main goal of the current study is to evaluate the effect of Fostair on the biomarkers of platelet activation in IPF disease which the investigator believes play a pivotal role in the pathogenesis of IPF and whether this translates in to a clinically beneficial effect of Fostair on IPF disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo inhaler | Placebo comparator | Drug: placebomatched placebo inhaler, to be taken 2 puffs, twice a day for 28 days |
| fostair | Experimental | Drug: fostairfostair 100mcg/6mcg 2pufss, twice a day. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects from 40 to 85 years of age
- Diagnosis of definite IPF according to American Thoracic Society / European respiratory symposium (ATS/ERS) Consensus Statement (2011) using either High-resolution computed tomography (HRCT) or surgical lung biopsy (SLB).
- Carbon monoxide transfer factor (TLco) of ≥ 30 % predicted ( historical measure accepted as long as within the last year).
- Able to maintain O2 saturation of ≥ 89% while breathing room air at rest.
- forced vital capacity (FVC) of 50-80% predicted value
Key exclusion criteria (9 listed)
- . Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.
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 |
|---|---|---|
| fostairAlso: beclometasone dipropionate and formoterol fumaratebeclometasone dipropionate 200mcg and formoterol 12 mcg delivered by inhaler, twice a day for 28 days | Drug | fostair |
| placeboplacebo matched inhaler 2puffs to be taken twice a day for 28 days | Drug | placebo inhaler |
Primary outcome
platelet-monocyte complex formation
Time frame: 1 month
Measurements will include platelet-monocyte complex formation measured at baseline, and post investigational treatments at Visit 5 and visit 8.
platelet P-selectin expression
Time frame: 1 month
platelet p selectin expression will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
platelet fibrinogen binding
Time frame: 1 month
Platelet fibrinogen binding will be measured at baseline, and post investigational treatments at Visit 5 and visit 8.
3 secondary outcomes
forced vital capacity
Time frame: visit1, visit 5 and visit 8
sputum eosinophils cells
Time frame: 1 month
six minute walk distance
Time frame: 1 month
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 15 Jul 2019.
- Results publicationWright C, Arnell K, Fraser S, et al. S46 An RCT of 28 day treatment with Fostair® pMDI 200/12 BD on platelet biomarkers in patients with Idiopathic Pulmonary Fibrosis. Thorax 2015;70:A29-A30.
- Publication LinkLink provided by the sponsor.
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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.
Simon Hart, MD principal investigator
Hull University Teaching Hospitals NHS 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 fostair in people with Idiopathic Pulmonary Fibrosis, run by Hull University Teaching 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 15 Jul 2019. 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?
platelet-monocyte complex formation (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048644, which also lists 1 linked publication.
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 15 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.