Asthma sufferers: participate in a trial of a medication to prevent worsening of asthma symptoms induced by colds

Many people with asthma have increased asthma symptoms when they have a cold.

The purpose of this study is to see if a new asthma medicine can reduce the increase in asthma symptoms that can follow when you have a cold.

If you are eligible and want to take part, participation will last nine weeks and require 11 visits, lasting less than one hour, to St Mary's Hospital in London Paddington. £1,500 compensation will be paid for your time, plus travel expenses.

What does the study involve?

To test whether this promising new class of drugs can lessen the asthma symptoms that follow a cold, the research team will recruit asthma sufferers and treat them with either the study's test drug, called OC459, or a placebo (a 'dummy pill'), before giving them a spray of the common cold virus in their nose. Participants will then be monitored closely for signs and symptoms of worsening asthma. Neither the investigators nor the subjects will know whether they are receiving the study drug or the placebo so as not to bias the results.

This trial will involve the use of a new drug called OC459. It has been chosen by the researchers because it has an excellent safety record: more than 750 subjects have taken OC459, including more than 450 subjects with asthma, with no drug-specific side effects noted.

The trial will also involve infection with the common cold virus (rhinovirus). This has been undertaken many times all over the world, including in three previous asthma studies at St Mary's Hospital, with no adverse events.

During the study the research team will perform a number of procedures that are routine practice in the hospital respiratory department. These include blood and breathing tests, sputum and nasal samples, and samples from the airways during a telescope test of the lungs, called bronchoscopy. No overnight stay will be required. Participants will also be asked to keep a daily record of their symptoms and basic breathing tests (e.g. peak flow) for the full nine weeks of the trial.

A participant information sheet outlining the study in greater detail is available on request.

Who can take part?

People with asthma aged 18-55 who use a 'preventer' inhaler daily, which can be either a steroid inhaler (e.g. Clenil) or combination inhaler (e.g. Symbicort or Seretide). Unfortunately people who smoke, are pregnant or breastfeeding will not be able to participate.

Potentially eligible volunteers will be invited to come to St Mary's Hospital for screening tests.

How to get involved

If you are interested in taking part and/or have any further questions, please contact the study team on: asthma.trial@imperial.ac.uk or contact 07590 250487.

This study is funded by the Medical Research Council (MRC) and conducted by a collaboration between UCL and the MRC-Asthma UK Centre, a joint Kings-Imperial initiative.

The study has been approved by the UCL Research Ethics Committee and National Research Ethics Committee (project ID number 15/LO/1666).

Dr Hugo Farne, Clinical Research Fellow at the MRC-Asthma UK Centre