Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Shannon Galgani
cough.research@manchester.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content

Help us improve the Be Part of Research website. Sign up to take part in online research.

Be Part of Research - Trial Details - oRIoN: An investigation into whether the methodology used in hypotonic saline cough challenge can be refined
Back

oRIoN: An investigation into whether the methodology used in hypotonic saline cough challenge can be refined

Recruiting

Open to: All Genders

Age: Mixed

Manchester

Medical Conditions

Chronic cough

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Refractory chronic cough (RCC) is cough that does not respond to treatment. It can have a profound effect on quality of life, with many patients coughing hundreds of times a day without any relief.
Cough challenge tests are used in research to measure how sensitive a person’s cough reflex is. These tests allow researchers to compare cough sensitivity between different people and different chest conditions, or before and after medication. This then helps researchers to understand why people develop a chronic cough and how their cough compares with healthy individuals.
The research team are doing this study to try to design a new cough challenge test that they hope could be used in the future to improve the diagnosis of chronic cough. Past studies have shown that cough challenge using hypotonic saline (low chloride, low sodium salty water) is good at distinguishing between people with chronic cough from healthy volunteers. However, the researchers believe this test could be done in a more simplified way. Moreover, the nebuliser and consumables currently used in hypotonic saline cough challenge are being withdrawn from use, so an alternative nebuliser must be found to allow research with this challenge to continue.
This study therefore aims to understand whether the current hypotonic saline cough challenge methodology can be refined while retaining its ability to identify patients with RCC versus healthy volunteers.
Phase A of the study will investigate whether we can shorten the hypotonic cough challenge protocol. This will be done by comparing how much people cough when asked to breathe in different amounts of saline solutions, compared to the original challenge.
Phase B will investigate whether an alternative nebuliser device can be used to conduct a hypotonic saline cough challenge. This will be done by comparing the cough response to hypotonic cough challenge using the original device, versus an alternative device.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

05 Oct 2026 19 Jan 2028

This study is split into two phases: Phase A and Phase B.

Phase A:
Phase A involves five visits to the clinical research ward at Wythenshawe Hospital, and a telephone follow up. At visit 1 a researcher will talk through the study and answer any questions. After signing a consent form, the researcher will confirm that the participant is eligible by going through their medical history, medication history and performing a blowing test (spirometry) to make sure the participants lungs work normally.
Participants with chronic cough will be asked to indicate the severity of their cough with a line on a 10 point scale known as a visual analogue scale and complete some cough-related questionnaires.

Cough challenge procedure:
First, the participant will be fitted with a cough monitor to record all sounds (specifically to count coughs) during the cough challenge. This will be removed prior to the end of the visit.
The participant will then be asked to wear a nose clip and will inhale the challenge agent (saline) using a nebuliser machine at decreasing osmolarities. This will be randomised to a hypo-osmolar saline solution or a control solution (normal 0.9% saline). The participant will be blinded to the challenge agent used but the researcher will know which agent is being used. The osmolarity of the saline will decrease until the participant wants to stop or the lowest osmolarity is reached. After the challenge the cough monitor will be removed, and the participant will repeat the blowing test. The participant will be asked to give feedback on how they found the challenge test. After this the visit will be over.

Visits 2-5 will follow the same procedures as visit 1, except that no further consent forms need to be completed. Each visit will take place 2-7 days after each other. Each visit will take about 1 hour. The final telephone visit will involve the researcher asking the participant about any changes in their health since the last visit, and should take about 15 minutes. After visit 6, Phase A of this study is over. Participants that take part in Phase A do not have to take part in Phase B, but may express interest in doing so on their consent form.

Phase B:
Phase B involves three visits to the clinical research ward at Wythenshawe Hospital and a telephone follow up.
At visit 1 a researcher will talk through the study and answer any questions. After signing a consent form, the researcher will confirm that the participant is eligible by going through their medical history, medication history and performing a blowing test (spirometry) to make sure the participants lungs work normally.
Participants with chronic cough will be asked to indicate the severity of their cough with a line on a 10 point scale known as a visual analogue scale and complete some cough-related questionnaires.

The participant will be asked to complete three cough challenges over three visits. However, in this phase, the only challenge agent being used will be hypotonic saline: it is the nebuliser device being used that will differ between the visits. Participants will complete a hypotonic saline cough challenge using the new and old device during the first two visits in a randomized order. In visit three, participants will complete the hypotonic saline cough using the new device again, to assess repeatability over time. Full blinding is not possible due the obvious difference between devices, but participants will not be told which device is the one currently being used, and which is the "new" alternate device. After the cough challenge, the visit will end.

Visit 2 will occur 2-7 days after visit 1. Visit 3 will take place 14-28 days after visit 2 to assess repeatability of the hypotonic saline cough challenge with the new device over time. Each visit is expected to take 1-1.5 hours.
The final telephone visit will involve the researcher asking the participant about any changes in their health since the last visit, and should take approximately 15 minutes. After this telephone call, Phase B is over.


1. Patients with refractory chronic cough (RCC) will be recruited from specialised cough clinics at Manchester Foundation Trust (MFT).
2. Healthy volunteers (i.e., those with no clinically relevant medical conditions or history of respiratory disease) will be recruited from across the University of Manchester and MFT.
Participants can be male or female, and must be aged 18 years or over. People on medication that may affect cough (e.g. ACE inhibitors, tricyclic antidepressants or opiate pain killers) cannot participate, as this may affect the results. People with asthma, that are pregnant or breastfeeding, that are currently smoking, vaping or have significant recreational drug use, also cannot take part.

You can take part if:



You may not be able to take part if:


All participants:1. Pregnancy or breastfeeding2. Upper or lower respiratory tract infection or significant change in pulmonary status within 4 weeks of enrolment3. Treatment with ACE inhibitors4. Treatment with tricyclic antidepressants5. Any therapy that may modulate cough (e.g. opioids, gabapentin)6. Patients with asthma7. Current or regular vaping <6 months8. Current or previous significant recreational drug use (including inhalation)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester University NHS Foundation Trust
    Southmoor Road Wythenshawe Hospital
    Manchester
    M23 9LT

There will be no direct benefit for participants in this study. However, we hope that the results of this study will help us to understand the mechanisms of coughing and improve treatments in the future.
Cough challenge tests which involve inhaling solutions designed to make participants cough. The solutions have been used in research for many years and have been shown to be safe. Hypotonic saline solutions may cause tightening of the airways in susceptible people (such as those with asthma), although this is rare. Breathing tests are performed before and after the test to monitor any chest tightening, which is easily treated by inhaling salbutamol (a medication to open up the airways). Patients with asthma are therefore excluded from this study and appropriately qualified medical professionals will be present in the department at all times should any participant feel unwell.

Ms Shannon Galgani
cough.research@manchester.ac.uk



The study is sponsored by University of Manchester and funded by Manchester Biomedical Research Centre; Vitalograph.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN41850796

Or CPMS: 72947

Last updated 08 October 2026

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top