top of page
Writer's pictureChristie Roberts

Snapshot- Respiratory Clinical Trials

These 'Snapshots' are part of a mini series quickly outlining some of my most memorable nursing shifts- the good, the bad and the ugly.

This first Snapshot is about a shift from my first year as a nursing student, waaaaay back in 2016! And it was the day that I discovered that clinical research existed, and was amazingly cool, and was an area I desperately wanted to work in someday.



I'd met a respiratory research nurse in a teaching session on my placement- her session had been about inhaler technique, but we digressed and she ended up telling us a bit about her role in the Oxford Respiratory Trials Unit (ORTU) and said that if anyone wanted to experience some research nursing, to send her an email. I had zero idea what kind of nursing I wanted to go into (I was only midway through 1st year, so that's okay!!!) but wasn't enjoying my surgical placement so sent her a message and arranged a day with her team.


She had been working on a trial for severe eosinophilic asthma- a relatively rare form of adult asthma in which WBCs cause swelling and inflammation in the airways. Typical asthma treatments, including inhaled corticosteroids, are usually ineffective and there's a distinct lack of other effective treatments that don't come with a barrage of nasty side effects.

A promising avenue was biologic agents and a phase 3 clinical trial had recently ended- MENSA- Mepolizumab as Adjunctive Therapy for Patients with Severe Asthma (I am still trying to figure out how that acronym works...). In Oxford, the trial was being lead by Prof Ian Pavord- something of a legend in the respiratory world (I met him 2 years later at an NIHR/BRC research open day and was a bit starstruck. He gave me some cracking careers advice). The study, published in the New England Journal of Medicine (see link below) found that 'treatment with mepolizumab reduced exacerbations by approximately one half, improved quality of life, and resulted in better asthma control'.


In January 2017, Mepo was approved by the MHRA for use in eosinophilic asthma. The drug is given as a subcutaneous injection every 4 weeks, and helps to reduce inflammation to prevent symptoms like SOB and wheeze. Cue my first day in ORTU, in January 2017. In a clinic, we met with participants from the trial. In this visit, baseline obs were taken and the participants were unblinded after almost a year in the trial.

The first patient we saw had been on Mepo rather than the placebo, and became very emotional talking about the incredible difference they had seen during the trial. They were usually hospitalised for around a week, every month, due to severe asthma attacks. Whilst taking part in the trial and taking Mepo, they had only had 3 asthma exacerbations, one requiring a hospital admission. To finish off the appointment, the patient was given their first official dose of Mepolizumab. It was the first dose being given outside of trial conditions in the UK, and I got to administer it.


I find it mindblowing to say that I gave the first dose of a brand new medicine, to a patient who had selflessly taken part in clinical research and had already felt the benefits of the results. Genuinely, one of the coolest moments of my entire life. It's a moment I think about a lot (and to this day it makes me a bit emotional to think about) and that's why this day sticks out so clearly as a career highlight.

What I find equally incredible is that on my 5th placement, a medical ward, a patient was admitted following an exacerbation of asthma. When going through his medications, I recognised the name of one of them- I did some digging, and he had been started on Mepo about a year earlier. I went to chat with him, and he told me about the huge difference Mepo had made- this was his first hospital admission since starting it! What a privilege to see research making such a difference to patients lives.


Following this incredible day, I worked a further 3 days across my 3 years as a student within ORTU but shadowing different teams.

This included the pleural team, looking at mesothelioma and malignant pleural effusion, and comparing indwelling pleural catheters to pleurodesis. This was the TIME2 (Trials in Malignant Effusion) trial, one part of a set of 3 trials looking at MPE. The chief investigator was Prof Najib Rahman- another Oxford based giant in respiratory med, who I had the pleasure of meeting in a few clinics. Jaen et al.,'s 2018 meta analysis gives a summary of MPE treatments. BTS guidelines were due to be updated in 2019/2020 to reflect the findings of the TIME2 trial- I think it's so rewarding to see those findings in action, and to see this research genuinely improving patients symptom burdens and quality of life.


I also spent time with the sleep team, who were exploring obstructive sleep apnoea in the MOSAIC trial, and a day in respiratory physiology which was an amazing opportunity to brush up on anatomy and see it in action.


The huge research scene was a big factor in me deciding to stay in Oxford post qualifying. Between the University of Oxford and OUH, and Oxford's reputation as a home for research, it seemed sensible to stay in the room where it happens. I'm so grateful for the set of circumstances that led to me being introduced to ORTU, and to clinical research nursing, because it really did give me a sense of direction and passion in my nursing. Although I (obviously) later discovered that I love ICU nursing too, clinical research nursing was the first speciality that I decided I truly liked. Since starting in ICU, I've spoken a lot to nurses who work part time clinically, and part time in research (although more on the academic rather than clinical side) and I'd love to find a role that blends my 2 dreams.



I hope you've enjoyed reading a bit about my experiences with clinical research nursing, and that it's maybe highlighted it as an area you hadn't considered working in? Keep your eyes peeled for future posts about clinical trials, and have a look at the references below if you want any more information about the trials mentioned in this post.


Love, Christie x





MENSA

Ortega, H., Liu, M., Pavord, I., Brusselle, G., FitzGerald, J., Chetta, A., Humbert, M., Katz, L., Keene, O., Yancey, S., Chanez, P. (2014) 'Mepolizumab treatment in patients with severe eosinophilic asthma' in New England Journal of Medicine. 371, pp. 1198-1207.

  • The MENSA trial. A multicentre, double-blinded, double-dummy RCT comparing 2 different dosages/preparations of an anti-interleukin 5 medication compared to a placebo. In total, 576 patients were randomized and 94% of these completed treatment. The primary outcome measure was the frequency of clinically significant asthma exacerbations- relative reduction rates for the 2 preparations of Mepo were 47% and 53% (P<0.001) compared to placebo. Secondary outcome measures included lung function (FEV1), quality of life, asthma control, self rated therapy responses by patients and clinicians and blood eosinophil levels

  • The protocol, developed by GSK, can be found here: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1403290/suppl_file/nejmoa1403290_protocol.pdf



Web MD 'What is eosinophilic asthma?' https://www.webmd.com/asthma/eosinophilic-asthma-causes#



TIME2

  • TIME2 is described as the 'first randomised controlled trial to directly compare Indwelling Pleural Catheters with chest tube and talc slurry pleurodesis for initial treatment of malignant pleural effusion'. The study ran from 2007-2011, with 106 patients randomised across 6 sites.

  • Findings were published in the ERJ- see link below


Mishra, E., Davies, H., Wrightson, J., Stanton, A., Guhan, A., Davies, C., Grayez, J., Harrison, R., Prasad, A., Crosthwaite, N., Lee, Y., Miller, R., Kahan, B., Rahman, N. (2012) 'The second therapeutic intervention in malignant effusion trial (TIME2): A randomised controlled trial to assess the efficacy and safety of patient controlled malignant pleural effusion drainage by indwelling pleural catheter compared to chest drain and talc slurry pleurodesis' in European Respiratory Journal. 40(56), p. 3074. https://erj.ersjournals.com/content/40/Suppl_56/3074


Jaen, A., Villalobos, R., Divinagracia, R., Tan, I. (2018) 'Indwelling pleural catheters vs pleurodesis for malignant pleural effusions: a meta analysis' in European Respiratory Journal. 52(62)


Roberts, M., Neville, E., Berrisford, R., Antunes, G., Ali, N. (2010) 'Management of a malignant pleural effusion: British Thoracic Society pleural disease guideline 2010' in Thorax. 65(2), pp. 32-40. https://thorax.bmj.com/content/thoraxjnl/65/Suppl_2/ii32.full.pdf


Recent Posts

See All

Kommentare


Post: Blog2 Post
bottom of page