We are recruiting volunteers with asthma, aged 18-55, for a respiratory trial to see whether the drug OC459 reduces asthma symptoms induced by colds.
Potential participants will be invited to come to St Mary's Hospital in London for screening tests. For patients who are eligible and want to take part in the trial, participation will last 9 weeks and require 11 visits to St Mary's Hospital.
Details about the study
This study will investigate whether a promising new class of drugs can prevent or lessen the worsening of symptoms following infection with the common cold.
To do so, the researchers will recruit patients with asthma and treat them with either the study’s test drug, called OC459, or a placebo (a ‘dummy pill’) before infecting them with the common cold virus. 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 an unlicensed drug called OC459. It has been chosen by the researchers because it has an excellent safety record: 750 subjects have taken OC459, including over 450 subjects with asthma, with no drug-specific side effects noted.
If you do decide to participate in this study, you will be provided with a participant information sheet outlining the study in greater detail.
The study will be recruiting participants from 18th January 2016 until the investigators have met their recruitment target, which may take 12-18 months.
Participants must have asthma and be aged between 18-55.
Potential participants will come to St Mary's Hospital, London for screening tests.
Participants will have a 50/50 chance of getting the study medicine as part of the trial. Every participant will be given a spray of a virus that causes the common cold into their nose. We will also perform a number of other procedures that are routine practice in the hospital. These include blood and breathing tests, sputum and nasal samples, and samples from the airways taken during a telescope test of the lungs, called bronchoscopy.
Participants will also be asked to keep a daily record of their symptoms and basic lung tests (e.g. peak flow) for the full 9 weeks of the trial.
For more information on what is involved in bronchoscopy, please contact email@example.com.
For patients who are eligible and want to take part in the trial, participation will last 9 weeks and require 11 visits to St Mary's Hospital.
You will be asked to keep a daily record of your symptoms and basic lung tests for the full 9 weeks of the trial.
No overnight stays will be required.