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Contact Information:

Mr James Wingfield Digby
-
cough.research@manchester.ac.uk


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Be Part of Research - Trial Details - Are ATP levels in the blood and airways higher in people with chronic cough?
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Are ATP levels in the blood and airways higher in people with chronic cough?

Not Recruiting

Open to: All Genders

Age: Adult

3.5 Mile Away
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.


Chronic refractory cough is a cough that does not respond to treatment. This can be extremely disruptive and has a profound effect on sufferers' lives, with patients sometimes coughing hundreds of times a day and unable to get any relief. Previous studies have shown that blocking a certain receptor on the nerves called P2X3 can dramatically reduce the number of times these patients cough. The mechanism behind this is currently unknown. This study aims to investigate whether people with chronic cough have higher levels of ATP, the substance which activates these receptors, in their lungs and their blood.

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:

01 Oct 2021 01 Jun 2024

The study involves three visits. The first visit is a screening visit, to make sure that people are suitable to take part in the study. After signing the consent form, a researcher will ask questions about medical history and any medication which participants may be taking. The participant’s height and weight will be measured, along with their blood pressure, heart-rate and oxygen levels. A doctor will perform a physical examination, which involves them listening to the participant’s chest with a stethoscope. There will be a blowing test to make sure that the participant’s lungs are normal, a blood sample will be taken and some questionnaires about cough to complete. When the research team are happy that the participant is suitable to be included in the study, the participant will be fitted with a cough monitor. This device will record all sounds made by the participant for 24 hours. The recording will then be processed and a researcher will count the number of coughs.
Following the cough recording, the participant will return to the hospital for a second visit to have a bronchoscopy. This is a test where a long, thin camera is inserted into the nose and down into the lungs. Patients who are already having this procedure done as part of their normal clinical care will be asked to participate in this study. Healthy volunteers would not normally have this test done. While the camera is in the lungs, samples will be taken for the study. These include bronchoalveolar lavage fluid (BALF) (where salt water is squirted into the lungs and sucked back out), brushings (where the airways are brushed to remove some cells) and biopsies (where small pieces of tissue from the airway are taken and pulled out when the camera is removed). Some people prefer to be sedated for this procedure as it can be uncomfortable. If this is the case, a cannula (tube) will be inserted into a vein in the participant’s arm for the sedative medication to be given through. Throughout the procedure, heart-rate and oxygen levels will be monitored. After the bronchoscopy, the participant will be monitored in the hospital until the doctor says that they have recovered enough to go home. The day after, a member of the research team will call to make sure that the participant is fully recovered and is well.
One to two weeks after the bronchoscopy, the participant will come back to the hospital for a follow-up visit. Any side effects from the bronchoscopy will be recorded and their blood pressure, heart-rate and oxygen levels measured. They will also be asked to perform another lung function test.


Samples from people with chronic cough will be compared to samples from healthy volunteers. Participants can be male or female, with chronic cough patients aged 18-80 years and healthy volunteers aged 45-80 years. People with no lung diseases, except chronic cough in the patient group, and those who have either never smoked or ex-smokers who only smoked a little can take part. People on any medication which might affect cough, such as ACE inhibitors and opiate pain-killers, cannot participate, as this might affect the results. People who might have a high ATP level for other reasons, such as people with long-term heart failure or those who exercise and train competitively, also cannot take part.

You can take part if:



You may not be able to take part if:


1. Have received any medications likely to modulate cough within 2 weeks of enrolment. They can be included if willing/able to discontinue these for the duration of the study.2. Currently taking ACE inhibitors3. Any condition that may increase circulating levels of ATP/ATP metabolites e.g. chronic cardiac failure, chronic hypoxia, vigorous exercise in the last 48 h, or regular vigorous exercise, such as professional sports or competitive training4. Pregnant or breastfeeding5. FEV1/FVC <70%6. Recent history of upper or lower respiratory tract infection or significant change in pulmonary status within 4 weeks of enrolment7. Other severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results


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

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

There are several risks associated with having a bronchoscopy. These include side effects of the sedative, low oxygen and a collapsed lung, although all of these are very rare. There is a risk of fever following a bronchoscopy, which may be increased by taking a BALF sample. This fever usually occurs around 8 hours after the procedure and gets better on its own. There is a slightly increased risk of bleeding in the airway if biopsies are taken. This bleeding is usually mild and does not require any treatment.
Taking part in this study will not benefit any participant directly. However, the researchers hope that the results of this study will help them to understand more about chronic cough and improve treatments in the future.

Mr James Wingfield Digby
-
cough.research@manchester.ac.uk



The study is sponsored by Manchester University Foundation Trust and funded by Wellcome Trust.



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Read full details for Trial ID: ISRCTN52011944

Or CPMS 50480

Last updated 27 January 2025

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